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:
1990

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
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:
MCP968 is a straw colored homogenous liquid. The MEHSL CRU number is 90163. This substance is stable for 6 months at 20C with an expiration date of 8/30/1990.

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
Male and female young adult New Zealand White rabbits obtained from Hazleton Research Products, Inc. (Denver, Pa) were used in this study. The male body weights ranged from 2.2-2.8 kilograms and the female body weights ranged from 2.2-2.7 kilograms. The animals were identified by individual ear tags and cage cards. The temperature of the study room was maintained at 68-72F with a relative humidity of 41-61%.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
The back of each animal was shaved prior to administration of the test substance. T he dose was applied evenly to the back of each animal followed by a layer of 8-ply gauze to cover the test site. The gauze was covered by a rubber dam and the anterior and posterior edges of the dam securely taped. A plastic Elizabethan collar was placed on each animal to prevent oral ingestion of the test substance and mechanical irritation of the test site.
Duration of exposure:
24h
Doses:
2gm/kg
No. of animals per sex per dose:
5 males and 5 females
Control animals:
not required
Details on study design:
Following a 24 hour exposure period, the dam and gauze were removed and the residual test substance wiped from the site. Clinical observations were recorded at approximately 1 and 4 hours after test substance administration and daily thereafter except on weekends. The condition of each animal (live, dead, moribund) was checked at least once daily. T he study was terminated after 14 days and each animal necropsied.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality
Clinical signs:
The following clinical obsrvations were noted in one or more animals: soft stool, decreased fecal output, diarrhea, decreased urinary output, and decreased food consumption.
Body weight:
There was an increase in mean and individual body weights during the study in relation to the Day 0 body weights with the exception of one male that lost 300 grams between days 7 and 14. This animal had diarrhea during the period of weight loss.
Gross pathology:
There were no gross pathological findings noted at necropsy that could be related to treatment

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 submission substance is greater than 2000 mg/kg bw in the New Zealand White rabbit. This finding does not warrant classification of the test material 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 test article 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 with the exception of one male that lost weight between days 7 adn 14. Soft stool, decreased fecal output, diarrhea, decreased urinary 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 test material is greater than 2.0 gm/kg. This finding does not warrant classification of the test material 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.