Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study report similar or equivalent to OECD 402. GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): MCP 917
- Physical state: homogeneous liquid
- Expiration date of the lot/batch: 04/01/1994
- Stability under test conditions: stable for 5 years
- Storage condition of test material: at room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hazleton Research Products, Inc. - Denver, PA
- Age at study initiation: young adult
- Weight at study initiation: Male: 2.5-3.0 kg; Female: 2.4-2.9
- Housing: Individually housed in suspended cages with wire mesh bottoms
- Diet (e.g. ad libitum): ~ 125 g of Purina rabbit chow no. 5326 daily
- Water (e.g. ad libitum): House water ad libitum

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Duration of exposure:
24 hours
Doses:
2 mg/kg
No. of animals per sex per dose:
5 per sex
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Body weights were recorded on Days 0, 7, and 14. Clinical observations were recorded at 1 and 4 hours after study substance administration and daily thereafter except on weekends.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
There were no deaths following administration of the study substance.
Clinical signs:
Soft stool, decreased fecal output, and decreased food consumption were noted in one or more animals.
Body weight:
There was an increase in mean and individual body weights during the study in relation to the Day 0 body weights.
Gross pathology:
There were no treatment-related gross pathological changes.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 for acute dermal toxicity of the study substance is greater than 2000 mg/kg bw in the New Zealand White rabbit. This finding does not warrant classification of the study substance as an acute dermal toxicant under the new Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
Executive summary:

The study substance was administered as a single dose for 24 hours to ten white rabbits at a concentration of 2000 mg/kg to assess acute dermal toxicity. Animals were observed for fourteen days following exposure. All animals survived to the termination of the study period. An increase in mean and individual body weights was observed during the study and soft stool, decreased fecal output, and decreased food consumption were noted in one or more animals. There were no treatment-related gross pathological changes. Based on the conditions of this study, the dermal LD50 for the study substance is greater than 2.0 gm/kg. This finding does not warrant classification of the study substance as an acute dermal toxicant under the new Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.