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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
not indicated
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Well documented non-GLP study performed according to a guideline similar to OECD Guideline 401. Only two animals per sex per dose level are used (instead of 5).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
Only 2 animals per sex per dose level are used instead of 5.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
- State of aggregation : liquid
- Appearance : colourless to yellow brown
Specific details on test material used for the study:
OTHER SPECIFICS:
- Name of test material (as cited in study report): Aus 0213 4236-14-4 Alkaline Corrosive Liquid N2 Pad Urethane Catalyst
- Appearance: orange liquid

Test animals

Species:
rat
Strain:
other: Crl:COBS CD (SD) BR
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Strain: Young albino rats: Charles River CD Strain, Crl:COBS CD (SD) BR
- Source: Charles River Breeding Laboratories, Inc., Wilmington, Massachusetts 01887
- Age at study initiation: young rats
- Weight at study initiation: males 180-232 g (mean 205.2 g); females 164-220 g (mean 194.8 g)
- Fasting period before study: 24 hours before oral intubation
- Housing: Animals were housed in suspended, wire-mesh stock cages
- Diet (e.g. ad libitum): permitted a standard laboratory diet: Purina Rat Chow 5012, Ralstor, Purina Company, St. Louis, Missouri 63188 (ad libitum)
- Water (e.g. ad libitum): water was permitted ad libitum
- Acclimation period: at least 5 days

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
or undiluted
Details on oral exposure:
Form administered: As a 10.0% (w/v) aqueous solution at 118.5-400,0 mg/kg and undiluted at 1350 - 4556 mg/kg.
Selected groups of albino rats were administered test material at several dose levels. All doses were administered directly into the stomachs of the rats using a hypodermic syringe equipped with a ball-tipped intubating needle.
Doses:
118,5; 400; 1350; 2025; 3038; 4556 mg/kg bw
No. of animals per sex per dose:
2
Control animals:
no
Details on study design:
After oral administration of the test material, the rats were housed individually in suspended, wire-mesh cages and observed for the following 14 days. Initial and final body weights, mortalities and reactions were recorded. A necropsy examination was conducted on all animals.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 025 mg/kg bw
Based on:
test mat.
Remarks on result:
other: SD = +/- 237.6 mg/kg
Mortality:
118,5 mg/kg group: 0 /4 dead
400 mg/kg group: 0/4 dead
1350 mg/kg group: 0/4 dead
2025 mg/kg group: 2/4 dead (1 female between 6-22h and 1 female after 1.5 days)
3038 mg/kg group: 4/4 dead (1 male and 1 female between 6-22h, 1 male after 1 day, 1 female after 2 days)
4556 mg/kg group: 4/4 dead (2 males after 4.5 days, 2 females between 6-22h)
Clinical signs:
Diuresis was observed in the 4556 mg/kg dose group in 2 animals.
Hypoactivity, hyperirritability, lacrimation and tremors were observed in the 2025 and 3038 mg/kg dose group.
Hemorrhagic lacrimation was observed in the 2025 mg/kg dose group in 1 animal.
Loss of balance was observed in the 3038 mg/kg dose group in 1 animal.
Body weight:
No adverse effects noted.
Gross pathology:
At 2025 mg/kg bw moderate postmortem autolysis was observed in 2 females
At 3038 mg/kg bw moderate postmortem autolysis was observed in one male and one female and slightly pale spleen was observed in one male
At 4556 mg/kg bw moderate postmortem autolysis was observed in two females and advanced postmortem autolysis was observed in two males.
Other findings:
No data

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
In this study an acute oral LD50 value of 2025 mg/kg bw was determined in rats after exposure to the substance. Therefore, the substance is considered not to be classified according to CLP.