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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
other: read across from similar substance
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Remarks:
Department of Toxicology, BASF AG
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: DR. K. Thomae GmbH, D-7950 Biberach, FRG
- Age at study initiation: young adults
- Weight at study initiation: mean 181 g (males), 174 g (females)
- Fasting period before study: at least 16h, with water ad libitum
- Housing: single housing in stainless steel wire mesh cages, Type DLK-III (Becker & Co., Castrop-Rauxel, FRG)
- Diet (e.g. ad libitum): Kliba-Labordiaet 343, Klingentalmuehle AG, Kaiseraugst, Switzerland; ad libitum
- Water (e.g. ad libitum): tap water; ad libitum
- Acclimation period: at least 1 week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
- Concentration of test material in vehicle: 11%
- Amount of vehicle (if gavage): 20 ml/kg bw
- Justification for choice of vehicle: aquous formulation corrresponds to the physiological medium


MAXIMUM DOSE VOLUME APPLIED: 20 ml/kg bw
Doses:
2200 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 day
- Frequency of observations and weighing: recording of signs and symptomps several times on the day of administration, at least once each workday; individually body weights shortly before application (day 0), and on days 7 and 13
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 200 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occured.
Clinical signs:
In the male and female animals was black discolored feces. Males additionally exhibited piloerection and black smeared fur in the anogenital area
Body weight:
Mean body weights (g) on days 0/7/13:
- Males: 181/244/247
- Females: 174/198/205
Gross pathology:
No pathological findings
Other findings:
Symptoms after administration of 2200 mg/kg bw of test material in vehicle by gavage:

Males:
day1-day2: piloerection (2/3 animals)
hour4-day2: discoloured feces (black) (3/3 animals)
hour4-day3: black smeared fur in the anogenital area (2/3 animals)

Females:
hour1-day1: discoloured feces (black) (3/3 animals)

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The analogue substance was tested for acute oral toxicity following OECD 401. The tested sample showed LD50 (rat, oral) > 2200 mg/kg bw, without mortality or gross pathological changes.