Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Remarks:
This study dates from 1981 and was conducted in a jurisdiction where toxicity testing on cosmetic ingredients was legally required to be conducted on vertebrate animals.
Type of information:
experimental study
Adequacy of study:
key study
Study period:
October 1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Justification for type of information:
This study dates from 1981 and was conducted in a jurisdiction where toxicity testing on cosmetic ingredients was legally required to be conducted on vertebrate animals.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
12 May 1981
Deviations:
yes
Remarks:
Only a single dose level was used in the study. This is considered not to effect the reliability of the test result.
GLP compliance:
no
Remarks:
The study was conducted in the USA in 1981, before the adoption of the OECD Principles of GLP in 1992.
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals

Species:
rat
Strain:
other: Albino, not otherwise specified.
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation:
222-270g

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5 male:5 female
Control animals:
not specified
Details on study design:
Ten (5M:5F) albino rats, 222-270 g, each received a single oral dose of the test article at a dose level of 5 grams per kilogram bodyweight. Animals were observed for pharmacologic activity and drug toxicity 1, 3, 6, and 21‘ hours after treatment, and daily thereafter for a total of 14 days. Non-survivors and animals surviving the ill day observation period were subjected to gross necropsy, with all findings noted. The test article was used as received (Sp.g. = 0.98).

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed during the test period.
Clinical signs:
Not reported.
Body weight:
Not reported.
Gross pathology:
No effects were observed during gross necropsy.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral LD50 in the rat of the test material was determined to be >5000 mg/kg bw under the conditions of the test.
Executive summary:

In this guideline (OECD 401) study, conducted prior to the adoption of GLP, the test material (EC 205-363-0) was determined to have an acute oral LD50 to rats of >5000 mg/kg bw. The study was conducted via oral gavage at a single dose level (5000 mg/kg bw) in albino rats. No toxicological effects were reported.