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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
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Reason / purpose:
read-across source
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
12 - 18 Mar 1991
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions. Only female animals tested; limited information on test substance and test protocol; observation period only 6 days.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
only female animals tested; limited information on test substance and test protocol; observation period only 6 days
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes
Species:
mouse
Strain:
other: NMRI EOPS
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 19-20 g
Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 6 mL/kg bw
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 6 days
- Frequency of observations and weighing: no data
Sex:
female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the study period.
Clinical signs:
No clinical signs of toxicity were observed up to the end of the observation period.
Body weight:
No effect on body weight was noted.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified
Reason / purpose:
read-across source
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
13 - 19 Mar 1991
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Comparable to guideline study with acceptable restrictions. No gross necropsy performed, no details on animal husbandry, observation period 7 days in the absence of mortality/signs of toxicity, few details on study protocol, analytical purity not given.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
no gross necropsy performed, no details on animal husbandry, few details on study protocol, observation period 7 days in the absence of mortality/signs of toxicity
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
mouse
Strain:
other: NMRI EOPS
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 19-20 g (range)
Route of administration:
oral: unspecified
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 5.8 mL/kg bw, (dose calculated assuming test substance density of 0.8550 g/mL)
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days (in the absence of mortality and signs of toxicity)
- Frequency of observations and weighing: mortality was recorded daily; the animals were observed daily for the presence of clinical signs; body weights were determined on Day 0 and 6
- Necropsy of survivors performed: no
Sex:
female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
There was no mortality during the study period.
Clinical signs:
No clinical signs of toxicity were observed up to the end of the 7-day observation period.
Body weight:
No effect on body weight was observed.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified
Reason / purpose:
read-across source
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given. Few details on study protocol were reported, no individual results were reported, the analytical purity of the test substance was not specified.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
few details on study protocol reported, no individual results reported
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes
Species:
mouse
Strain:
other: NMRI EOPS
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 20 g
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
5 mL/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Sex:
female
Dose descriptor:
LD50
Effect level:
> 5 mL/kg bw
Based on:
test mat.
Sex:
female
Dose descriptor:
LD50
Effect level:
> 4 350 mg/kg bw
Based on:
test mat.
Remarks on result:
other: calculated based on density (0.87 g/cm³)
Mortality:
No deaths occured during the study period.
Clinical signs:
No abnormal reaction was observed.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified

Data source

Materials and methods

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Isononyl Isononanoate
- Physical state: liquid

Results and discussion

Effect levels
Dose descriptor:
LD50
Effect level:
> 4 350 mg/kg bw

Applicant's summary and conclusion

Conclusions:
Based on read-across from the structurally similar substances, the available data on oral toxicity do not meet the classification criteria according to Regulation (EC) 1272/2008 or Directive67/548/EEC, and are therefore conclusive but not sufficient for classification.
Executive summary:

No acute toxicity data is available for isononyl isononanoate. Therefore, assessment of acute toxicity via the oral and dermal route is conducted by means of read-across. No mortality was observed in acute oral toxicity studies performed with the analogue substances isopropyl laurate (CAS 10233-13-3), 3,5,5 -trimethylhexyl 3,5,5-trimethylhexanoate (CAS 59219-71-5) and isononanoic acid, C16-18 alkyl esters (CAS 111937-03-2) (Dufour, 1991; Dufour, 1991; Masson, 1986; Potokar; 1970). Based on the results of these studies, the overall oral acute LD50 is > 4350 mg/kg bw.