Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
poor documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report Date:
1973

Materials and methods

Test guideline
Qualifier:
no guideline followed
Version / remarks:
study pre-dates creation of guidelines but a method similar to OECD TG 402 is likely
Principles of method if other than guideline:
4 hours dermal treatment with subsequent observation
GLP compliance:
no
Remarks:
pre-guideline study
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Test animals

Species:
rat
Strain:
not specified
Sex:
male
Details on test animals and environmental conditions:
- Weight at study initiation: 260 - 280 g (mean 270 g)

Administration / exposure

Type of coverage:
occlusive
Vehicle:
propylene glycol
Details on dermal exposure:
TEST SITE
- Area of exposure: 25 cm2
- Type of wrap if used: gauze patch, covered with plastic

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5000 mg/kg bw

- For solids, paste formed: moistened with propylene glycol
Duration of exposure:
4 hours
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
4 males
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: after 4 hours, 2, 6, 9, 13 and 14 days
- Frequency of weighing: after 2, 6, 9, 13, 14 days

Results and discussion

Effect levels
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
no mortality observed
Clinical signs:
at the first two readings after 4 hours and 2 days the treated skin was discoloured by the test material. In addition, reddened skin was noted in 2 animals.
Body weight:
All animals showed expected gains in body weight over the observation period.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Regulation (EC) No. 1272/2008
Conclusions:
The acute oral median lethal dose (LD50) of the test item in male rats was determined to be greater than 5000 mg/kg body weight (Globally Harmonized Classification System - Unclassified).
The test item did not meet the criteria for classification according to Regulation (EC) No. 1272/2008.
Executive summary:

In a pre-guideline study the acute dermal toxicity was investigated in 4 male rats.

In a limit test the acute oral median lethal dose (LD50) of the test item in male rats was determined to be greater than 5000 mg/kg body weight (Globally Harmonized Classification System - Unclassified).

The test item did not meet the criteria for classification according to Regulation (EC) No. 1272/2008.