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Description of key information

In a GLP guideline study from 1990, the LD50 (oral, gavage) of the test substance in male/female rats was found to be >2000 mg/kg bw (corresponding to 960 mg/kg bw act. ingr.). 1/5 female rats died and had clinical symptoms and pathological findings. 4/5 female and 5/5 male rats survived without any findings. However, since the dye content was only 48% and the content of active ingredient too low to exclude a classification according to CLP criteria, a second study from 1974 (equivalent to guideline study) was taken into account for a weight-of-evidence approach: under the study conditions, the LD50 (oral, gavage) of the test substance in male rats was determined at 2115 mg/kg bw (act. ingr.). Based on both results, the substance is not classifiable according to CLP criteria.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
Oct 1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
Male rats were administered the test substance by oral gavage. The application was followed by a 14-d observation period and thereafter the animals were sacrificed.
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
Breeder: Winkelmann, Borchen
Age: ca. 8 weeks old
Body weight: 150-200 g
Temperature and relative humidity: 22 +/- 1.5°C and 60 +/- 5%, respectively
Light period: 12 h light - 12 h dark
Feed: Altromin R 1324
Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
Dose volume applied: 20 mL/kg bw
Doses:
3000, 3500, 4000, 4500, 5000, 6300 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Other examinations performed: clinical signs
Statistics:
Probit analysis
Sex:
male
Dose descriptor:
LD50
Effect level:
4 068 mg/kg bw
Based on:
test mat.
95% CL:
> 3 735 - < 4 418
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
2 115 mg/kg bw
Based on:
act. ingr.
Mortality:
0/10 at 3000 mg/kg bw, 3/10 at 3500 mg/kg bw, 5/10 at 4000 mg/kg bw, 7/10 at 4500 mg/kg bw, 8/10 at 5000 mg/kg bw, 10/10 at 6300 mg/kg bw
Clinical signs:
Sedation, breathing difficulties, seizures
Interpretation of results:
GHS criteria not met
Conclusions:
Under the study conditions, the LD50 (oral, gavage) of the test substance in male rats was determined at 2115 mg/kg bw (act. ingr.). The substance is not classifiable according to CLP criteria.
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
13 - 27 Feb 1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Version / remarks:
"Richtlinie 84/449/EWG (Amtsblatt der Europäischen Gemeinschaften Nr. L 251 vom 19.09.1984, S.93)"
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
Breeder: Winckelmann, Borchen
Acclimatization period: at least 5 d
Age: 8-10 weeks old
Body weight: 174-192 g
Temperature and relative humidity: 22 +/- 2°C and 55 +/- 5%, respectively
Light period: 12h light/12h dark
Diet and water: Altromin 1324 and tap water, ad libitum
Fasting period before study: 16 - 4 h
Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
The test substance was diluted into water and administered at a constant rate (10 mL/kg bw) by gavage
Doses:
2000 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: pior to, 1 week after and 2 weeks after application
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology
Statistics:
according to Spärman & Kärber
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 960 mg/kg bw
Based on:
act. ingr.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
Male: 0/5; female: 1/5 (on day 2)
Clinical signs:
Male: none; female: bad general condition, sedation, prone position in 1/5 animals (ca. 8 h after application)
Body weight:
No treatment related effects
Gross pathology:
Male: no effects; female: gastric mucosa elapsed and all organs in the abdominal cavity blue stained in 1/5 animals
Other findings:
None
Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 (oral, gavage) of the test substance in male/female rats was found to be >2000 mg/kg bw (corresponding to 960 mg/kg bw act. ingr.). 1/5 female rats died and had clinical symptoms and pathological findings. 4/5 female and 5/5 male rats survived without any findings.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 115 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification