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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:
weight of evidence
Study period:
12 Jun 1991 - 26 Jun 1991
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions. Lack of test material details, no necropsy performed.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
lack of test material details, no necropsy performed
Qualifier:
according to
Guideline:
other: FHSA/CPSC: Federal Hazardous Substances Control Act, 16 CFR 1500.3
Deviations:
no
GLP compliance:
not specified
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): only trade name given
- Physical state: white flaky solid
- Analytical purity: no data
- Lot/batch No.: Lot# 12735

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hilltop Lab Animals, Scottdale, PA, USA
- Age at study initiation: young adult, not further specified
- Weight at study initiation: 184-205 g
- Fasting period before study: 18 h
- Housing: individually in suspended stainless steel caging with mesh floors
- Diet: pelleted Purina Rat Chow #5012, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22


Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
2.5%
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 25% w/w
- Amount of vehicle (if gavage): 2.0-2.3 mL/kg bw

MAXIMUM DOSE VOLUME APPLIED: 2.3 mL/kg bw




Doses:
5000 mg/kg bw administered as two doses due to the volume of test material of 2.0-2.3 mL each within 24h.
No. of animals per sex per dose:
5
Control animals:
other: not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: the rats were observed for signs of gross toxicity and mortality at 1, 2, 3, 4, 5 and 24 h post-dosing, and at least once daily thereafter for 14 days. Body weights were recorded initially and at termination (Day 14).
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: administered as two doses within 24 h.
Mortality:
No mortalities occurred.
Clinical signs:
No abnormal clinical signs were observed.
Body weight:
Normal body weight gain.
Gross pathology:
Not examined.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified