Registration Dossier

Administrative data

Description of key information

Key information has been conducted according to recognised testing guidelines, prior to the adoption of the OECD principles of GLP in 1992.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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.
Reference:
Composition 0
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 information:
Composition 1
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
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).
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.
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
1

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available
Quality of whole database:
1

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
1

Additional information

Justification for classification or non-classification

The acute oral LD50 in the rat was determined to be >5000 mg/kg bw, therefore the registered substance is not considered classified as acutely toxic according to the criteria of the Classification, Labelling, and Packaging (CLP) regulation (1272/2008)