Registration Dossier

Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
Only 3 animals used per test group
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female

Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: Saline
Details on dermal exposure:
TEST SITE
- % coverage: 10%

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not washed
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): ~20-25 ml


Duration of exposure:
24 hours
Doses:
20 000 mg/kg
No. of animals per sex per dose:
3/sex/group
Control animals:
no
Details on study design:
2 females and 1 male received the substance applied to abraded skin, 2 males and 1 female received the substance on intact skin.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 20 000 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
In-life signs observed within 24 hours of dosing included motor activity decrease and ataxia. Other signs included fecal staining/soft stool, nasal discharge, ocular discharge, collar removed by animal, piloerection, motor activity increase and aggressive behaviour

Body weight:
A slight loss of weight was noted in one abraded animal and a failure to gain weight was exhibited by two non-abraded animals.
Gross pathology:
No effects specified

Applicant's summary and conclusion

Interpretation of results:
relatively harmless
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 Dantoin DMH >20000mg/kg.