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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study report equivalent or similar to OECD guideline (420): GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): MRD-85-608
- Physical state: yellow liquid
- Analytical purity: assumed 100%

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Breeding Laboratories, Stone Ridge, NY
- Age at study initiation: approximately 10 weeks
- Weight at study initiation: males (295-321 g), females (209-215 g)
- Fasting period before study: 12 hours
- Housing: 5 per cage
- Diet (e.g. ad libitum): Purina certified rodent chow, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 22 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-21
- Humidity (%): 40-70
- Air changes (per hr): n.a
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 5000 mg/kg
Doses:
5000 mg/kg (5.75 ml/kg based on a density of 0.87 g/ml)
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 1, 2, 4, and 6 hours after dosing and daily thereafter for 14 days.
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology
Statistics:
Means and standard deviations of the body weights.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Remarks on result:
other: No deaths observed
Mortality:
No deaths observed
Clinical signs:
Minimal adverse clinical events were observed. Unthrifty coat and ano-genital staining being the most frequently noted. Soft stool, oral discharge, thin hair coat and scab on tail were also noted at a low incidence. No observable abnormalities were seen between days 6 through 14 post exposure.
Body weight:
No effects
Gross pathology:
7 of the 10 test animals had no effects. Lungs mottled red were observed in three animals.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral LD50 for CAS# 98072-31-2 is greater than 5000 mg/kg.
Executive summary:

The acute oral toxicity of CAS# 98072-31-2 was evaluated when administered to 5 male and 5 female rats by oral gavage at the limit dose of 5000 mg/kg.  Observations were made as to the nature, onset, severity, and duration of toxicological signs 1, 2, 4, and 6 hours after dosing and daily thereafter for 14 days.  Minimal adverse clinical signs were observed.  All animals survived to study termination.  The acute oral LD50 for CAS# 98072-31-2 is greater than 5000 mg/kg.