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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information

No reproduction toxicity data are available for aluminium tribenzoate, the endpoint is filled by read across (rationale is attached in section 13). There are several publications and evaluations available for both the benzoate and aluminium ion. Based on the results of a feeding study with benzoic acid over 4 generations (chosen as key study), the NOAEL for reproduction was established to be at least 1% in feed, which correlates to approximately 430 mg aluminium tribenzoate/kg bw/day. Studies available on the aluminium part indicated a higher NOAEL for reproduction toxicity.

Link to relevant study records
Reference
Endpoint:
multi-generation reproductive toxicity
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
The rationale to read across the data is attached in Section 13.
Reason / purpose for cross-reference:
read-across source
Mortality:
no mortality observed
Description (incidence):
The average survival (F0 and F1-generation) was slightly increased in the dosed groups compared to the control groups (average lifespan in days: 785 ± 20, 899 ± 28 and 827 ± 25 for the control group and the groups dosed at 0.5% and 1,0%, respectively).
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
no effects observed
Food efficiency:
no effects observed
Organ weight findings including organ / body weight ratios:
no effects observed
Histopathological findings: non-neoplastic:
no effects observed
Reproductive performance:
no effects observed
Description (incidence and severity):
The percentage of sterile females was 15%, 10% and 4% for the control group and the groups exposed to 0.5% and 1% in feed, respectively. The average number of pups per nest was 9.0 ± 0.33, 9.5 ± 0.26 and 9.6 ± 0.29 (after first mating, all generations) and 6.9, 7.7 and 7.5 (second mating, F1 only) for the control group and the groups exposed to 0.5% and 1% in feed, respectively. The survival of pups after the first three weeks was slightly lower for the exposed groups (74%, 66% and 65% (after first mating, all generations) and 72%, 61% and 73% (second mating, F1 only) for the control group and the groups exposed to 0.5% and 1% in feed, respectively). This is expected to be related to the higher number of pups, and not to the exposure to the test item. There was no effect seen on onset of menopause.
Key result
Dose descriptor:
NOAEL
Effect level:
>= 1 other: %
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: No adverse effects seen up to and including 1% benzoic acid in feed.
Key result
Dose descriptor:
NOAEL
Effect level:
>= 430 mg/kg bw/day (actual dose received)
Based on:
test mat.
Remarks:
Aluminium tribenzoate
Sex:
male/female
Basis for effect level:
other: No adverse effects seen up to and including 1% benzoic acid in feed.
Key result
Critical effects observed:
no
Mortality / viability:
mortality observed, non-treatment-related
Description (incidence and severity):
The survival of pups after the first three weeks was slightly lower for the exposed groups (74%, 66% and 65% (after first mating, all generations) and 72%, 61% and 73% (second mating, F1 only) for the control group and the groups exposed to 0.5% and 1% in feed, respectively). This is considered to be related to the higher number of pups, and not to the exposure to the test item.
Key result
Dose descriptor:
NOAEL
Generation:
other: F0, F1, F2 and F3
Effect level:
>= 1 other: %
Based on:
test mat.
Remarks:
benzoic acid
Sex:
male/female
Basis for effect level:
other: No effects seen up to and including the highest dose tested.
Key result
Dose descriptor:
NOAEL
Generation:
other: F0, F1, F2 and F3
Effect level:
>= 430 mg/kg bw/day (actual dose received)
Based on:
test mat.
Remarks:
Aluminium tribenzoate
Sex:
male/female
Basis for effect level:
other: No effects seen up to and including the highest dose tested.
Key result
Critical effects observed:
no
Key result
Reproductive effects observed:
no
Conclusions:
Based on the results of a feeding study with benzoic acid over 4 generations, the NOAEL for reproduction toxicity was established to be at least 1% in feed. This result is read across to aluminium tribenzoate, which results in a NOAEL of at least 430 mg/kg bw/day. The rationale to read across the data is attached in section 13.
Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
430 mg/kg bw/day
Study duration:
chronic
Species:
rat
Quality of whole database:
The study was considered to be reliable (Klimisch 2).
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

Based on the results of a feeding study with benzoic acid over 4 generations, the NOAEL for reproduction toxicity was established to be at least 1% in feed. This result is read across to aluminium tribenzoate, which results in a NOAEL of at least 430 mg/kg bw/day. The rationale to read across the data is attached in section 13.

Effects on developmental toxicity

Description of key information

No developmental toxicity data are available for aluminium tribenzoate, the endpoint is filled by read across (rationale is attached in section 13).

A study by the FDA was identified as the key study. The teratologic potential was in detail assessed in a study during which pregnant mice, rats, rabbits and hamsters were exposed to sodium benzoate. No effects were seen at the highest dose tested, therefore the NOAEL for aluminium tribenzoate was established to be at least 188 mg/kg bw/day. Studies available on the aluminium part indicated a higher NOAELs for developmental toxicity.

Link to relevant study records

Referenceopen allclose all

Endpoint:
developmental toxicity
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
The rationale to read across the data is attached in Section 13.
Reason / purpose for cross-reference:
read-across source
Analytical verification of doses or concentrations:
no
Clinical signs:
not specified
Mortality:
mortality observed, non-treatment-related
Description (incidence):
No mortality occurred in the control group and in the groups exposed to 14.0, 65.0 and 300.0 mg/kg bw/day. One female died in the group exposed to 3.0 mg/kg bw/day (killed on day 13 after abortion).
Body weight and weight changes:
no effects observed
Description (incidence and severity):
The body weight increase of pregnant dams was comparable between the groups exposed to sodium benzoate and the control group.
Number of abortions:
no effects observed
Description (incidence and severity):
One female exposed to 3.0 mg/kg bw/day aborted on day 13. This was considered to be incidental and not related to the test item exposure. No other abortions were observed in the groups exposed to the test item or in the control group.
Pre- and post-implantation loss:
no effects observed
Description (incidence and severity):
The average number of corpora lutea per dam was 15.7, 15.2, 14.7, 14.9 and 15.1 for the negative control group and the groups exposed to 3.0, 14.0, 65.0 and 300.0 mg/kg bw/day, respectively. The average number of implantation sites per dam was 13.2, 11.6, 11.9, 12.2 and 12.3 for the negative control group and the groups exposed to 3.0, 14.0, 65.0 and 300.0 mg/kg bw/day, respectively. The average number of live fetuses per dam were 12.9, 11.1, 11.3, 11.8 and 11.9 for the negative control group and the groups exposed to 3.0, 14.0, 65.0 and 300.0 mg/kg bw/day, respectively. The exposure to the test substance did not have an effect on implantation loss.
Total litter losses by resorption:
no effects observed
Description (incidence and severity):
All pregnant dams had live litters.
Early or late resorptions:
effects observed, non-treatment-related
Description (incidence and severity):
The total number of resorptions was 6, 8, 12, 8 and 9 for the negative control group and the groups exposed to 3.0, 14.0, 65.0 and 300.0 mg/kg bw/day, respectively. The percentage of dams with partial resorptions was 27.3%, 23.8%, 40.9%, 31.8% and 28.6% for the negative control group and the groups exposed to 3.0, 14.0, 65.0 and 300.0 mg/kg bw/day, respectively.
Dead fetuses:
effects observed, non-treatment-related
Description (incidence and severity):
The total number of dead fetuses was 2, 2, 2, 2 and 1 for the negative control group and the groups exposed to 3.0, 14.0, 65.0 and 300.0 mg/kg bw/day, respectively.
Changes in number of pregnant:
effects observed, non-treatment-related
Description (incidence and severity):
One female exposed to 3.0 mg/kg bw/day aborted on day 13. This was considered to be incidental and not related to the test item exposure. No other abortions were observed in the groups exposed to the test item or in the control group.
Key result
Dose descriptor:
NOAEL
Effect level:
>= 322 mg/kg bw/day (actual dose received)
Based on:
test mat.
Remarks:
Aluminium tribenzoate
Remarks on result:
other: No adverse effects observed up to and including the highest dose tested.
Key result
Abnormalities:
no effects observed
Fetal body weight changes:
no effects observed
Description (incidence and severity):
The average fetus weight was 1.81, 1.84, 1.80, 1.84 and 1.86 g for the control group and the groups exposed to 3.0, 14.0, 65.0 and 300.0 mg/kg bw/day, respectively.
Changes in sex ratio:
no effects observed
Description (incidence and severity):
The sex ratio (M/F) for the live fetuses was 0.45, 0.52, 0.45, 0.62 and 0.43 for the control group and the groups exposed to 3.0, 14.0, 65.0 and 300.0 mg/kg bw/day, respectively. All values for the exposed groups were comparable to the sex ratio in the control group.
External malformations:
no effects observed
Skeletal malformations:
effects observed, non-treatment-related
Description (incidence and severity):
The number of skeletal malformations in the exposed groups did not differ from the control group (results summarized below) and/or did not show a dose-related increase and were therefore considered not to be related to the test item.
Visceral malformations:
no effects observed
Description (incidence and severity):
No soft tissue abnormalities were observed in any of the groups.
Key result
Dose descriptor:
NOAEL
Effect level:
>= 322 mg/kg bw/day (actual dose received)
Based on:
test mat.
Remarks:
Aluminium tribenzoate
Sex:
male/female
Basis for effect level:
other: No adverse effects seen up to and including the highest dose tested
Key result
Abnormalities:
no effects observed
Key result
Developmental effects observed:
no

 

Control

3.0 mg/kg bw/day

14.0 mg/kg bw/day

65.0 mg/kg bw/day

300.0 mg/kg bw/day

Live

fetuses

examined

(pregnant

dams)

195/22

163/21

171/22

178/22

171/21

Sternebrae

incomplete ossification

101/22

85/20

98/21

102/21

92/21

Bipartite

18/14

20/13

22/16

23/16

14/10

Extra

-

-

6/1

-

1/1

Missing

18/11

7/5

32/13

17/8

14/8

Ribs

More than 13

20/15

35/17

34/16

23/11

29/20

Vertebrae

Incomplete ossification

-

-

3/3

-

-

Extremities

Incomplete closure

-

-

2/2

1/1

-

Miscellaneous

Hyoid, missing

-

-

5/2

-

-

Hyoid, reduced

-

-

-

-

1/1

 

Numerator = number of foetuses affected; Denominator = Number of litters effected

Conclusions:
Hamsters were exposed to sodium benzoate at 0, 3.0, 14.0, 65.0 and 300.0 mg/kg bw/day via oral gavage for 10 consecutive days during pregnancy (gestation days 6 to 15). At sacrifice on day 14, No effects were seen in maternal animals or fetuses. The nature and number of skeletal abnormalities in the test groups did not differ from the controls. No soft tissues abnormalities were observed. Based on these results, it is concluded that the NOAEL (maternal and development) is at least 300 mg/kg bw/day in hamsters. This result is read across to aluminium tribenzoate, resulting in a NOAEL of at least 322 mg/kg bw/day). The rationale to read across the data is attached in Section 13.
Endpoint:
developmental toxicity
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
The rationale to read across the data is attached in Section 13.
Reason / purpose for cross-reference:
read-across source
Limit test:
no
Clinical signs:
not specified
Mortality:
mortality observed, non-treatment-related
Description (incidence):
Two pregnant females in the control group died, both on day 17. In the groups exposed to sodium benzoid all pregnant females survived until sacrifice.
Body weight and weight changes:
no effects observed
Description (incidence and severity):
The body weight increase of pregnant dams was comparable between the groups exposed to sodium benzoate and the control group.
Number of abortions:
no effects observed
Description (incidence and severity):
No abortions were observed in the groups exposed to the test item or in the control group.
Pre- and post-implantation loss:
no effects observed
Description (incidence and severity):
The average number of implantation sites per dam was 12.5, 11.6, 12, 10.8 and 11.8 for the negative control group and the groups exposed to 1.75, 8.0, 38.0 and 175.0 mg/kg bw/day, respectively. The average number of live fetuses per dam were 11.4, 11.1, 11.5, 9.76 and 10.4 for the negative control group and the groups exposed to 1.75, 8.0, 38.0 and 175.0 mg/kg bw/day, respectively. The exposure to the test substance did not have an effect on implantation loss.
Total litter losses by resorption:
no effects observed
Description (incidence and severity):
All pregnant dams had live litters.
Description (incidence and severity):
The total number of resorptions was 20, 8, 11, 18 and 21 for the negative control group and the groups exposed to 1.75, 8.0, 38.0 and 175.0 mg/kg bw/day, respectively. The percentage of dams with partial resorptions was 63.2%, 31.6%, 42.9%, 47.6% and 60.0% for the negative control group and the groups exposed to 1.75, 8.0, 38.0 and 175.0 mg/kg bw/day, respectively.
Dead fetuses:
effects observed, non-treatment-related
Description (incidence and severity):
No dead fetuses were found in the control group. In the groups exposed to 1.75, 8.0, 38.0 and 175.0 mg/kg bw/day, 2, 2, 4 and 6 dead fetuses were found, respectively. The number of dams with one or more dead fetuses was 0 (control group) and 2, 1, 4, 4 in the groups exposed to 1.75, 8.0, 38.0 and 175.0 mg/kg bw/day, respectively.
Key result
Dose descriptor:
NOAEL
Effect level:
>= 188 mg/kg bw/day (actual dose received)
Based on:
test mat.
Remarks:
Aluminium tribenzoate
Basis for effect level:
other: No adverse effects seen up to and including the highest dose tested.
Key result
Abnormalities:
no effects observed
Fetal body weight changes:
no effects observed
Description (incidence and severity):
The average fetus weight was 0.84, 0.89, 0.64 0.86 and 0.90 g for the control group and the groups exposed to 1.75, 8.0, 38.0 and 175.0 mg/kg bw/day, respectively.
Changes in sex ratio:
no effects observed
Description (incidence and severity):
The sex ratio (M/F) for the live fetuses was 0.64, 0.97, 0.72 0.95 and 0.76 g for the control group and the groups exposed to 1.75, 8.0, 38.0 and 175.0 mg/kg bw/day, respectively.
External malformations:
no effects observed
Skeletal malformations:
effects observed, non-treatment-related
Description (incidence and severity):
The number of skeletal malformations in the exposed groups did not differ from the control group (results summarized below) and/or did not show a dose-related increase and were therefore considered not to be related to the test item.
Visceral malformations:
no effects observed
Description (incidence and severity):
No soft tissue abnormalities were observed in any of the groups.
Key result
Dose descriptor:
NOAEL
Effect level:
>= 188 mg/kg bw/day (actual dose received)
Based on:
test mat.
Remarks:
Aluminium tribenzoate
Sex:
male/female
Basis for effect level:
other: No adverse effects seen up to and including the highest dose tested
Key result
Abnormalities:
no effects observed
Key result
Developmental effects observed:
no

 

Control

1.75 mg/kg bw/day

8.0 mg/kg bw/day

38.0 mg/kg bw/day

175.0 mg/kg bw/day

Live

fetuses

examined

(pregnant

dams)

151 (19)

147 (19)

172 (21)

143 (21)

146 (20)

Sternebrae

incomplete ossification

72/17

52/14

65/16

80/18

59/18

Bipartite

5/4

-

5/4

5/5

6/6

Fused

-

6/6

-

-

-

Missing

35/11

26/9

31/11

30/9

10/5

Ribs

More than 13

12/5

16/8

15/7

16/8

13/12

Vertebrae

Incomplete ossification

-

-

1/1

2/2

-

Extremities

Incomplete ossification

3/2

-

13/3

2/2

1/1

Miscellaneous

Hyoid, missing

32/11

48/15

52/15

67/17

31/11

Hyoid, reduced

25/11

16/9

24/16

15/11

17/12

 

Numerator = number of foetuses affected; Denominator = Number of litters affected

Conclusions:
Mice were exposed to sodium benzoate at 0, 1.75, 8.0, 38.0 and 175.0 mg/kg bw/day via oral gavage for 10 consecutive days during pregnancy (gestation days 6 to 15). No effects were seen in maternal animals or fetuses. The nature and number of skeletal abnormalities in the test groups did not differ from the controls. No sof tissues abnormalities were observed. Based on these results, it is concluded that the NOAEL (maternal and development) is at least 175 mg/kg bw/day in mice. This result is read across to aluminium tribenzoate, resulting in a NOAEL of at least 188 mg/kg bw/day). The rationale to read across the data is attached in Section 13.
Endpoint:
developmental toxicity
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
The rationale to read across the data is attached in Section 13.
Reason / purpose for cross-reference:
read-across source
Clinical signs:
not specified
Mortality:
mortality observed, non-treatment-related
Description (incidence):
All pregnant rabbits in the control group and exposed to 12.0 mg/kg bw/day survived until gestation day 20. Three females exposed to 2.5 mg/kg bw/day aborted (on day 14 (one female) and day 23 (two females)) and were killed. Other pregnant females died, which were dosed at 54.0 mg/kg bw/day (day 18) or 300 mg/kg bw/day (day 27). In absence of a dose-related increase of mortality, the observed deaths were not considered related to the test item exposure.
Body weight and weight changes:
no effects observed
Description (incidence and severity):
The body weight increase of pregnant rabbits was comparable between the groups exposed to sodium benzoate and the control group.
Number of abortions:
effects observed, non-treatment-related
Description (incidence and severity):
No abortions were observed in the control group and in the exposed groups, except for two females aborted in the group exposed to 2.5 mg/kg bw/day (both on day 23). As this only happened in the lowest dose group, this observations were considered incidental.
Pre- and post-implantation loss:
no effects observed
Description (incidence and severity):
The average number of corpora lutea per dam was 10.0, 9.44, 9.71, 9.86 and 14.8 for the negative control group and the groups exposed to 2.5, 12.0, 54.0 and 250.0 mg/kg bw/day, respectively. The average number of implantation sites per dam was 5.9, 5.4, 5.5, 4.64 and 7.22 for the negative control group and the groups exposed to 2.5, 12.0, 54.0 and 250.0 mg/kg bw/day, respectively. The average number of live fetuses per dam were 5.2, 3.9, 3.6, 1.36 and 5.89 for the negative control group and the groups exposed to 2.5, 12.0, 54.0 and 250.0 mg/kg bw/day, respectively. The exposure to the test substance did not have an effect on implantation loss.
Total litter losses by resorption:
effects observed, non-treatment-related
Description (incidence and severity):
The percentage of rabbits with complete resorptions was 10.0%, 0%, 10%, 54.6% and 11.1% for the negative control group and the groups exposed to 2.5, 12.0, 54.0 and 250.0 mg/kg bw/day, respectively.
Early or late resorptions:
effects observed, non-treatment-related
Description (incidence and severity):
The total number of resorptions was 6, 6, 10, 5 and 20 for the negative control group and the groups exposed to 2.5, 12.0, 54.0 and 250.0 mg/kg bw/day, respectively. The percentage of dams with partial resorptions was 17.4%, 16.7%, 34.8%, 21.7% and 30.4% for the negative control group and the groups exposed to 2.5, 12.0, 54.0 and 250.0 mg/kg bw/day, respectively. As a high incidence was only observed in a single dose group and not at highest dose, this observation was considered incidental.
Dead fetuses:
effects observed, non-treatment-related
Description (incidence and severity):
The total number of dead fetuses was 1, 1, and 6 for the negative control group and the groups exposed to 2.5 and 12.0 mg/kg bw/day, respectively. No other dead fetuses were observed. At 12.0 mg/kg bw/day, the 6 dead fetuses were obserevd in one rabbit (full litter loss). As no dead fetuses were seen at higher doses, this was considered to be incidental.
Key result
Dose descriptor:
NOAEL
Effect level:
>= 269 mg/kg bw/day (actual dose received)
Based on:
test mat.
Remarks:
Aluminium tribenzoate
Basis for effect level:
other: No adverse effects observed up to and including the highest dose tested.
Key result
Abnormalities:
no effects observed
Fetal body weight changes:
no effects observed
Description (incidence and severity):
The average fetus weight was 38.0, 35.4, 36.6, 41.9 and 38.6 g for the control group and the groups exposed to 2.5, 12.0, 54.0 and 250.0 mg/kg bw/day, respectively.
Changes in sex ratio:
no effects observed
Description (incidence and severity):
The sex ratio (M/F) for the live fetuses was 0.73, 1.44, 0.89, 0.5 and 0.77 for the control group and the groups exposed to 2.5, 12.0, 54.0 and 250.0 mg/kg bw/day, respectively.
External malformations:
no effects observed
Skeletal malformations:
effects observed, non-treatment-related
Description (incidence and severity):
The number of skeletal malformations in the exposed groups did not differ from the control group (results summarized below) and/or did not show a dose-related increase and were therefore considered not to be related to the test item.
Visceral malformations:
no effects observed
Description (incidence and severity):
No soft tissue abnormalities were observed in any of the groups.
Key result
Dose descriptor:
NOAEL
Effect level:
>= 269 mg/kg bw/day (actual dose received)
Based on:
test mat.
Remarks:
Aluminium tribenzoate
Sex:
male/female
Basis for effect level:
other: No adverse effects seen up to and including the highest dose tested
Key result
Abnormalities:
no effects observed
Key result
Developmental effects observed:
no

 

Control

2.5 mg/kg bw/day

12.0 mg/kg bw/day

54.0 mg/kg bw/day

250.0 mg/kg bw/day

Live

fetuses

examined

(pregnant

dams)

50/9

39/10

36/8

15/5

53/8

Sternebrae

incomplete ossification

-

1/1

1/1

-

-

Bipartite

-

-

1/1

-

-

Fused

-

2/2

-

1/1

-

Extra

2/2

2/2

1/1

-

3/2

Skull

Craniostasis

-

-

1/1

-

-

 

Numerator = number of foetuses affected; Denominator = Number of litters effected

Conclusions:
Rabbits were exposed to sodium benzoate at 0, 2.5, 12.0, 54.0 and 250.0 mg/kg bw/day via oral gavage for 13 consecutive days during pregnancy (gestation days 6 to 18). At sacrifice on day 29, no effects were seen in maternal animals or fetuses. The nature and number of skeletal abnormalities in the test groups did not differ from the controls. No substance-related soft tissues abnormalities were observed. Based on these results, it is concluded that the NOAEL (maternal and development) is at least 250 mg/kg bw/day in rats. This result is read across to aluminium tribenzoate, resulting in a NOAEL of at least 269 mg/kg bw/day). The rationale to read across the data is attached in Section 13.
Endpoint:
developmental toxicity
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
The rationale to read across the data is attached in Section 13.
Reason / purpose for cross-reference:
read-across source
Clinical signs:
not specified
Mortality:
no mortality observed
Description (incidence):
All rats survived until gestation day 20.
Body weight and weight changes:
no effects observed
Description (incidence and severity):
The body weight increase of pregnant dams was comparable between the groups exposed to sodium benzoate and the control group.
Number of abortions:
no effects observed
Description (incidence and severity):
No abortions were observed in the groups exposed to the test item or in the control group.
Pre- and post-implantation loss:
no effects observed
Description (incidence and severity):
The average number of corpora lutea per dam was 11.5, 12.7, 11.9, 12.0 and 11.2 for the negative control group and the groups exposed to 1.75, 8.0, 38.0 and 175.0 mg/kg bw/day, respectively.The average number of implantation sites per dam was 10.8, 12.5, 10.3, 11.7 and 11.0 for the negative control group and the groups exposed to 1.75, 8.0, 38.0 and 175.0 mg/kg bw/day, respectively. The average number of live fetuses per dam were 10.6, 12.3, 9.91, 11.4 and 10.1 for the negative control group and the groups exposed to 1.75, 8.0, 38.0 and 175.0 mg/kg bw/day, respectively. The exposure to the test substance did not have an effect on implantation loss.
Total litter losses by resorption:
effects observed, non-treatment-related
Description (incidence and severity):
All pregnant dams had live litters, except for one dam exposed to 38.0 mgkg bw/day, which suffered total litter loss by resorption. This was considered an incidental finding.
Early or late resorptions:
effects observed, non-treatment-related
Description (incidence and severity):
The total number of resorptions was 6, 6, 10, 5 and 20 for the negative control group and the groups exposed to 1.75, 8.0, 38.0 and 175.0 mg/kg bw/day, respectively. The percentage of dams with partial resorptions was 17.4%, 16.7%, 34.8%, 21.7% and 30.4% for the negative control group and the groups exposed to 1.75, 8.0, 38.0 and 175.0 mg/kg bw/day, respectively.
Dead fetuses:
no effects observed
Description (incidence and severity):
No dead fetuses were found in any of the groups (except in the positive control group).
Changes in number of pregnant:
no effects observed
Key result
Dose descriptor:
NOAEL
Effect level:
>= 188 mg/kg bw/day (actual dose received)
Based on:
test mat.
Remarks:
Aluminium tribenzoate
Basis for effect level:
other: No adverse effects observed up to and including the highest dose tested.
Key result
Abnormalities:
no effects observed
Fetal body weight changes:
no effects observed
Description (incidence and severity):
The average fetus weight was 3.67, 3.70, 3.70, 3.89 and 3.81 g for the control group and the groups exposed to 1.75, 8.0, 38.0 and 175.0 mg/kg bw/day, respectively.
Changes in sex ratio:
no effects observed
Description (incidence and severity):
The sex ratio (M/F) for the live fetuses was 1.15, 1.10, 0.81, 0.80 and 1.00 for the control group and the groups exposed to 1.75, 8.0, 38.0 and 175.0 mg/kg bw/day, respectively.
External malformations:
no effects observed
Skeletal malformations:
effects observed, non-treatment-related
Description (incidence and severity):
The number of skeletal malformations in the exposed groups did not differ from the control group (results summarized below) and/or did not show a dose-related increase and were therefore considered not to be related to the test item.
Visceral malformations:
no effects observed
Description (incidence and severity):
No soft tissue abnormalities were observed in any of the groups, except for one pup in the group exposed to 38.0 mg/kg bw/day, which had subcutaneous edema. This was considered to be an incidental finding.
Key result
Dose descriptor:
NOAEL
Effect level:
>= 188 mg/kg bw/day (actual dose received)
Based on:
test mat.
Remarks:
Aluminium tribenzoate
Sex:
male/female
Basis for effect level:
other: No adverse effects seen up to and including the highest dose tested
Key result
Abnormalities:
no effects observed
Key result
Developmental effects observed:
no

 

Control

1.75 mg/kg bw/day

8.0 mg/kg bw/day

38.0 mg/kg bw/day

175.0 mg/kg bw/day

Live

fetuses

examined

(pregnant

dams)

161/23

196/24

151/23

175/22

155/23

Sternebrae

incomplete ossification

13/9

10/6

12/8

14/8

8/7

Bipartite

-

-

-

2/2

-

Missing

1/1

-

-

-

1/1

Ribs

Wavy

11/5

2/1

1/1

5/4

3/3

Vertebrae

Incomplete ossification

1/1

-

-

2/2

-

Skull

Incomplete closure

23/9

21/9

11/7

21/12

19/10

Miscellaneous

Hyoid, missing

22/8

12/9

8/4

15/8

18/11

Hyoid, reduced

-

4/4

1/1

3/3

5/4

 

Numerator = number of foetuses affected; Denominator = Number of litters effected

Conclusions:
Rats were exposed to sodium benzoate at 0, 1.75, 8.0, 38.0 and 175.0 mg/kg bw/day via oral gavage for 10 consecutive days during pregnancy (gestation days 6 to 15). At sacrifice on day 20, no effects were seen in maternal animals or fetuses. The nature and number of skeletal abnormalities in the test groups did not differ from the controls. No substance-related soft tissues abnormalities were observed. Based on these results, it is concluded that the NOAEL (maternal and development) is at least 175 mg/kg bw/day in rats. This result is read across to aluminium tribenzoate, resulting in a NOAEL of at least 188 mg/kg bw/day). The rationale to read across the data is attached in Section 13.
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
188 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
The study was considered to be reliable (Klimisch 2).
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available
Additional information

Rats were exposed to sodium benzoate at 0, 1.75, 8.0, 38.0 and 175.0 mg/kg bw/day via oral gavage for 10 consecutive days during pregnancy (gestation days 6 to 15). At sacrifice on day 20, no effects were seen in maternal animals or fetuses. The nature and number of skeletal abnormalities in the test groups did not differ from the controls. No substance-related soft tissues abnormalities were observed. Based on these results, it is concluded that the NOAEL (maternal and development) is at least 188 mg/kg bw/day in rats. This result is read across to aluminium tribenzoate, resulting in a NOAEL for developmental toxicity of at least 188 mg/kg bw/day. In parallel, the study was performed in mouse, hamster and rabbit. In none of these studies adverse effects were seen up to and including the highest dose tested (NOAELs 188 mg/kg bw/day or higher). The rationale to read across the data is attached in Section 13.

Justification for classification or non-classification

Based on the available data, aluminium tribenzoate is not classified for reproduction and developmental toxicity according to CLP Regulation (EC) No. 1272/2008.

Additional information