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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given.

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:
other: 16 CFR 1500.40
Deviations:
yes
Remarks:
limited documentation
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: yellow liquid
- Analytical purity: no data

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
not specified

Administration / exposure

Type of coverage:
occlusive
Vehicle:
not specified
Details on dermal exposure:
TEST SITE
- Area of exposure: clipped skin of the trunk
- Type of wrap if used: the area was covered with gauze and wrapped with impervious material (not further specified).

REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test material was removed (not further decribed)
- Time after start of exposure: 24 h
Duration of exposure:
24 h
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10 (including 5 animals treated on intact and 5 animals treated on abraded skin; no details on the gender available).
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed daily and individual body weights were determined on Day 0 and Day 14 of the study period.
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, body weight, skin irritation (24 h after application of the test substance)

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the study period.
Clinical signs:
Slight to moderate diarrhea was observed in 5/10 animals on Days 8 to 14. Slight yellow discharge around the nose of one animal was observed on Days 6, 9 and 10 and worsened on Days 11 through 14.
On Day 1, all 5 animals with intact skin and 4/5 animals with abraded skin showed moderate erythema according to the Draize scoring system. One animal with abraded skin showed slight erythema formation. No edema were observed in any animal (shaved or abraded) after 24 h.
Body weight:
Body weight gains of all animals were within the normal ranges.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified