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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: study was performed prior to OECD guideline and GLP but follows principles thereof.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
1981
Deviations:
no
GLP compliance:
no
Remarks:
prior to GLP requirements
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Details on Test material
- Name of test material (as cited in study report): Crotylchlorid, technisch
- Substance type: clear liquid
- Physical state: liquid
- Batch: not reported

Test animals

Species:
rat
Strain:
other: Bor: WISW (SPF TNO)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: F. Winkelmann, Borchen, Germany
- Weight at study initiation: male: 145 g, female 121 g
- Fasting period before study: 16h
- Housing: 1-5 animals per cage
- Diet (e.g. ad libitum): R10, Ssniff
- Water: libitum
- Acclimation period: 4-8 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +- 1°C
- Humidity (%): 60 +- 5%
- Air changes (per hr): 15 per hour
- Photoperiod (hrs dark / hrs light): 12/12


Administration / exposure

Route of administration:
oral: gavage
Vehicle:
petrolatum
Details on oral exposure:
VEHICLE
details not given


MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg


Doses:
251, 316, 398, 501, 631 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical signs up to 6h and then daily body weight day 1, 7 and 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight:
Statistics:
LD50 determination according to Litchfield and Wilcoxon, 95% confidence interval

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
385 mg/kg bw
95% CL:
324 - 488
Mortality:
males/females (out of 5)
251 mg/kg bw: 0/0
316 mg/kg bw: 1/0
398 mg/kg bw: 3/3
501 mg/kg bw: 4/5
631 mg/kg bw: 5/5
Death occurred within 24-48 hours post application
Clinical signs:
No macroscopic changes were seen at necropsy.
Clinical symptoms included diarrhoea, ataxia, staggered gait, hunched posture, sedation. Up to ten days after treatment the animals showed signs of intoxication.
Body weight:
The treatment with test substance did not influence bodyweight gain.
Gross pathology:
dead animals showed reddened mucosa in the stomach and gut, all other animals showed no signs.
Other findings:
- Potential target organs: CNS

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Remarks:
Migrated information
Conclusions:
Under conditions tested, the LD50 of the test substance was calculated to be 385 mg/kg body weight. Mortality is considered to be mainly due to its corrosive properties, however, clinical signs may be indicative of possible neurotoxicity.