Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
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 401.

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 401 (Acute Oral 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: 5 years at room temperature
- Storage condition of test material: room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Taconic Farms, Germantown, NY
- Weight at study initiation: Male: 245-374g; Female: 189-270g
- Fasting period before study: overnight

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
5 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: Signs of toxicity were recorded at ~ 1/2, 1 and 4 hours after study substance administration and daily thereafter with the exception of weekends. Body weights were recorded prior to fasting and on Days 0, 7, and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, and gross pathology

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no deaths following administration of the study substance.
Clinical signs:
There were several clinical observations noted in one or more animals: decreased activity, urogenital staining (yellow), anogenital staining (yellow-brown), chromodacryorrhea, and alopecia (forelimbs).
Body weight:
There was an increase in mean and individual body weights during the study in relation to the prefast 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:
Based on the parameters of this study, the acute oral LD50 for the study substance is >5.0 g/kg in the rat. This finding does not warrant the classification as an acute oral 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:

In this study, ten rats were given a single 5.0 g/kg dose of the study substance by oral gavage. The rats were then observed for 14 days and a gross examination was performed at the termination of the study period. All animals survived to termination of the study period. There was an increase in mean and individual body weights in relation to the pre-fast body weights. Decreased activity, urogenital and anogenital staining, alopecia and chromodacryorrhea were observed in one or more animals. There were no treatment-related gross pathological changes. Based on the parameters of this study, the acute oral LD50 for the study substance is >5.0 g/kg in the rat. This finding does not warrant the classification of the study substance as an acute oral 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.