Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
10 September 1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Justification for type of information:
Limited scopes for methodological differences with an acute dermal toxicitystudy, therefore should be suitable to be used. As the study has been conducted on the susbtance and the toxicity profile is consistent, to prevent use of unnecessary animal testing this data should be considered and used.

Data source

Reference
Reference Type:
other: Study abstract
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Specific details on test material used for the study:
Physical Description Brown Solid
Test material was grounded and applied as an aqeous slurry

Test animals

Species:
rabbit
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
No Data

Administration / exposure

Type of coverage:
not specified
Vehicle:
not specified
Details on dermal exposure:
The test skin of all animals were abraded
Doses:
200, 794, 3160 mg/kg
No. of animals per sex per dose:
2 males and 2 females per dose
Control animals:
no
Details on study design:
Animals were treated dermally as an aqeous paste made from grounded test substance. Animals were observed for 14 Days for signs of mortality and clinical signs. Macrospic evaluation was performed at the end of the study.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 3 160 mg/kg bw
Based on:
test mat.
Mortality:
Motality was observed in 1/4 animals at 794 and at 3160 mg/kg
Clinical signs:
The material was severely irritating to the skin was observed through the observation period. Pale red to red, well-defined erythema, moderate edema and second degree burns at 200 mg/kg were observed. Pale red to red, well-defined erythema, severe edema and second degree burns at 794 and 3160 mg/kg were observed. Escharosis and fissuring were noted at all test sites of all survivors at 7 and 14 days.
Body weight:
Decreases in Bodyweight effects were noted in surviving 3 animals treated at 3160 mg/kg at observation Day 7. By day 14 animal bodyweights had partially recovered back to starting weights in 2 animals. One animal's bodyweight remained similar to Day 7.
Gross pathology:
No test related findings.

Any other information on results incl. tables

Dose Level (mg/kg)

Animal Number and Sex

Mortality

200

1-M

0/4

2-M

3-F

4-F

794

5-M

1/4

6-M

7-F

8-F

3160

9-M

1/4

10-M

11-F

12-F

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
LD50 = 3160 mg/kg
Executive summary:

The objective of this study was to assess the adverse effects which can follow within a short period of time after a single dermal application of the Substanc.

 

The Substance was administered to 3 groups of male and female, albino rabbits. The study design was as follows:

 

Table1
Experimental Design

 

Group
Numbers

Number of Animals

Dose Level
(mg/kg)

1

2 Males & 2 Females

200

2

2 Males & 2 Females

794

3

2 Males & 2 Females

3160

 

The following parameters and end points were evaluated in this study: clinical signs, body weights, body weight changes, and on Day 14, gross necropsy findings.

 

Mortality was observed in 1 animal treated at 3160 mg/kg bw day and 1 animal treated at 794 mg/kg bw day. Decreases in Bodyweight effects were noted in surviving 3 animals treated at 3160 mg/kg at observation Day 7. By day 14, animal bodyweights had partially recovered back to starting weights in 2 animals. One animal's bodyweight remained similar to Day 7.

The material was severely irritating to the skin was observed through the observation period. Pale red to red, well-defined erythema, moderate oedema and second degree burns at 200 mg/kg were observed. Pale red to red, well-defined erythema, severe oedema and second degree burns at 794 and 3160 mg/kg were observed. Escharosis and fissuring were noted at all test sites of all survivors at 7 and 14 days. No macroscopic findings were considered to be test related findings.

 

Under the conditions of the study the median lethal dose level (LD50) of the Substance in albino rabbits were considered to be 3160 mg/kg.