Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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

Description of key information

No repeated dose 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 was established to be at least 1% in feed, which correlates to approximately 430 mg aluminium tribenzoate/kg bw/day.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records
Reference
Endpoint:
chronic toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
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
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
Gross pathological findings:
no effects observed
Histopathological findings: non-neoplastic:
no effects observed
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 highest dose tested.
Critical effects observed:
no

Based on the default values as proposed in TNO report V98 the average body weight rat in a chronic study is appr. 375 g (male and female). According to the authors, the average intake was approximately 150 mg benzoic acid/ rat, which corresponds to an exposure of appr. 400 mg/kg bw/day. In order to adjust this value from the source chemical (benzoic acid) to the target chemical (aluminium tribenzoate), the following calculation is used: NOAEL benzoate = 400 mg/kg bw/d. Based on a molecular weight of aluminium tribenzoate (MW=390.33), the benzoate ion (MW=121.11) has a weight percentage of 93.09%. Therefore, the adjusted NOAEL for aluminium tribenzoate is calculated to be 430 mg/kg bw/day ((400 mg/kg bw/day/ 93.09)*100).

Conclusions:
Based on the results of a feeding study with benzoic acid over 4 generations, the NOAEL was established to be at least 1% in feed, which correlates to approximately 400 mg/kg bw/day. This result is read across to alumnium tribenzoate (see rationale attached in section 13).
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
430 mg/kg bw/day
Study duration:
chronic
Species:
rat
Quality of whole database:
The key study was considered to be reliable (Klimisch 2).

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Based on the results of a feeding study with benzoic acid over 4 generations, the NOAEL was established to be at least 1% in feed, which correlates to approximately 400 mg/kg bw/day. This result is read across to alumnium tribenzoate (see rationale attached in section 13). The corresponding NOAEL is appr 430 mg/kg bw/day, based on no adverse effects seen at the highest dose tested.

Justification for classification or non-classification

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