Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
September, 1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
(1981)
Deviations:
yes
Remarks:
lack of the study design and test material details in the report
GLP compliance:
no
Remarks:
(study performed prior to GLP was in place)
Test type:
standard acute method
Limit test:
yes

Test material

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

Test animals

Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
No data

ENVIRONMENTAL CONDITIONS
No data

Administration / exposure

Type of coverage:
not specified
Vehicle:
not specified
Details on dermal exposure:
No data
Duration of exposure:
No data
Doses:
5000 mg/kg


No. of animals per sex per dose:
10 animals (sex unknown)
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Frequency of weighing: no data
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
1 animal died on day 14
Clinical signs:
Diarrhea, difficulty in walking due to severe skin reaction, lethargy, emaciation, ataxia, yellow nasal discharge, adipsia, anorexia, tachypnea, mucous in stool, respiratory rattle (no data about which clinical sign when was observed in which animal).
Body weight:
No data
Gross pathology:
See section "Any other information on results incl. tables"
Other findings:
- Erythema (redness) (day 1): Moderate in 4 of the 10 animals; Severe in 6 of the 10 animals
- Edema (day 1): Moderate in 10 of the 10 animals

Any other information on results incl. tables

 

Necropsy observations; Number of animals

Normal

3

Exudate, nose/mouth yellow

1

Exudate, anogenital, brown

1

Intestines, areas yellow

1

Intestines, bloated

3

Liver dark

1

Liver, mottled

1

Lungs, areas dark

2

Lungs, bright orange

2

Kidney dark

2

Kidney, mottled

2

Kidney, white nodules

1

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In an acute dermal toxicity study with 10 rabbits, performed equivalent to OECD 402 (1981), a LD50 of >5000 mg/kg bw was determined.
Executive summary:

The substance was tested in an acute dermal toxicity study (limit test) with 10 rabbits, performed equivalent to OECD 402 (1981). One animal died on day 14. Diarrhea, difficulty in walking due to severe skin reaction, lethargy, emaciation, ataxia, yellow nasal discharge, adipsia, anorexia, tachypnea, mucous in stool and respiratory rattle was observed among the animals. Moderate to severe erythema and moderate edema was observed on day 1. Based on the results, a LD50 of >5000 mg/kg bodyweight was determined. Based on this result, the substance does not need to be classified for acute toxicity by the dermal route in accordance with the CLP Regulation.