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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
08/08/1989 - 08/23/1989
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable well-documented study report which meets basic scientific principles: GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): MCP 922
- Physical state: Liquid
- Color: Amber
- Storage: Ventilation
- Stability: 2 years at room temp
- Expiration date of the lot/batch: 06/25/1991
- Other: Preparation of test substance: stirring is optional

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, New York
- Weight at study initiation: males = 275 - 412 grams, females = 199 - 269 grams
- Fasting period before study: Overnight prior to dosing
- Housing: individual housing, suspended cages with wire mesh bottoms
- Diet (e.g. ad libitum): Purina certified rodent chow, No. 5002, ad libitum
- Water (e.g. ad libitum): house water, ad libitum via automatic watering system
- Acclimation period: at least 12 days


ENVIRONMENTAL CONDITIONS
- Temperature (°F): 72 °F
- Humidity (%): 47 - 54%
- Photoperiod (hrs dark / hrs light): 12 hours light/dark cycle

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 5.0 gm/Kg
Doses:
5.0 gm/Kg
No. of animals per sex per dose:
5 male, 5 female
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations = 1/2, 1, and 4 hours after test substance administration and once daily thereafter with the exception of weekends. Weighings = recorded prior to fasting and on Days 0, 7, and 14.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 other: gm/kg
Mortality:
All animals survived to end of study
Clinical signs:
The following were noted in one or more animals: chromorhinorrhea, and decreased fecal output
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:
There were no gross pathological 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:
The LD50 for the test material is greater than 5.0 gm/Kg in both male and female rats. These findings do not warrant 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.
Executive summary:

The test material was administered by oral gavage to 5 male and 5 female Sprague Dawley rats at the dose of 5.0 mg/kg to assess the acute oral LD50. Clinical observations were made at 1/2, 1, and 4 hours after test substance administration and daily thereafter with the exception of weekends. There was an increase in mean and individual body weights during the study in relation to the prefast body weights. There were no deaths following administration of the test substance. At the end of the study, the LD50 was determined to be greater than 5.0 mg/kg. These findings do not warrant 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.