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. Performed in a manner equivalent or similar to OECD Method 401. 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 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:
MCP 968 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:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Male and female young adult Sprague-Dawley rats obtained from Taconic Farms (Germantown) NY were used in this study. The body weights ranged from 239-533 grams for the males and 182-321 grams for the females. The animals were identified by individual ear tags and cage cards. The temperature of the study room was maintained at 70-73F with a relative humidity of 27-74%

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
All animals were fasted overnight and dosed via oral gavage. Body weights were recorded prior to fasting and on Days 0,7, and 14. Food was returned to each animal immediately after dosing
Doses:
5.0 gm/kg
No. of animals per sex per dose:
5 male and 5 females
Control animals:
no
Details on study design:
Signs of toxicity were recorded at approximately 0.5, 1 and 4 hours after test substance administration and daily thereafter with the exception of weekends and holidays. The condition of each animal (live, dead, moribund) was checked once daily. All animals were necropsied at the termination (day 14) of the study.

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
Clinical signs:
The following clinical observations were noted in one or more of the animals: soft stool, urogenital discharge, and anal discharge.
Body weight:
there was an increase in mean body weights and individual body weights during the study in relation to the prefast body weights.
Gross pathology:
No changes noted during 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:
Based on the parameters of this study, the acute oral LD50 for the submission 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 test material 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. The following clinical observations were noted in one or more of the animals: soft stool, urogenital discharge, and anal discharge. There were no treatment-related gross pathological changes. Based on the parameters of this study, the acute oral LD50 for the test material is >5.0 g/kg in the rat. This finding does not warrant the classification of the test material 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.