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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:
other information
Reliability:
1 (reliable without restriction)

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)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Purity > 99%
Impurities: 2-chlorobenzyl chloride and 2-chlorobenzotrichloride each < 0.2%

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: HOECHST AG, Kastengrund, SPF-Zucht
- Age at study initiation: no data
- Weight at study initiation: males: 181 g - 211 g (average 195 g); females: 174 g - 195 g (average 184 g)
- Fasting period before study: about 16 hours
- Housing: 5 animals per makrolon cage
- Diet: Altromin 1324 rat diet, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 55 +/- 10%
- Air changes (per hr): no data
- Photoperiod: 12 hrs dark / 12 hrs light

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Sesame oil
Details on oral exposure:
- Concentration in vehicle: 25%
MAXIMUM DOSE VOLUME APPLIED: 2.5, 3.15, 4.0, 4.24, 4.48, 5.6, 6.4, 10.0 ml/kg bw



Doses:
630, 800, 1000, 1060, 1120, 1400, 1600, 2500 mg/kg bw
No. of animals per sex per dose:
5 animals per sex per dose
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of weighing: weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology, histopathology

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
1 130 mg/kg bw
95% CL:
> 954 - < 1 400
Sex:
female
Dose descriptor:
LD50
Effect level:
595 mg/kg bw

Applicant's summary and conclusion

Conclusions:
The LD50 value for acute oral toxicity is 1130 mg/kg bw in male Wistar rats and 595 mg/kg bw in female Wistar rats.