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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
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.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
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

Test material

Constituent 1
Reference substance name:
111973-03-2
IUPAC Name:
111973-03-2
Details on test material:
- Name of test material (as cited in study report): isononanoate de cetearyl
- Physical state: transparent liquid
- Lot/batch No.: 0510 C

Test animals

Species:
mouse
Strain:
other: NMRI EOPS
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 19-20 g (range)

Administration / exposure

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

Results and discussion

Effect levels
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.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified