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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
July 1983
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study was performed according to OECD Guideline 401 and GLP

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Version / remarks:
EEC Directive 79-831 Annex V, Part B 4.1.1.
GLP compliance:
yes
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
- Strain specifics: Hoe: WISKf (SPF71)
- Source: Hoechst AG, Kastengrund, SPF-breed
- Age at study initiation: 8 - 10 weeks
- Weight at study initiation: male 191 g - 199 g, female 187 g - 208 g
- Fasting period before study: approximately 16 hours before treatment, access to water permitted
- Housing: in groups of five in Makrolon type 4 cages with standard softwood bedding
- Diet (e.g. ad libitum): standard rat diet (Albtromin 1324) ad libidum
- Water (e.g. ad libitum): tap water ad libidum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2°C
- Humidity (%): 55 ± 10 %
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: sesame oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 0.2 g/ml
- Amount of vehicle (if gavage): 20 ml/kg body weight, application volume was distributed over one hour (test item in vehicle administered)
Doses:
5000 mg/kg body weight
No. of animals per sex per dose:
5 males
5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 15 days starting with treatment day 1
- Frequency of observations and weighing:
mortality/viability: during the first 30 minutes and approximately 1, 2, and 4 h after administration on day 1 and daily on days 2-15
clinical signs: during the first 30 minutes and approximately 1, 2, 3 and 6 h after administration on day 1 and daily on days 2-15
body weights: on days 1 (prior to administration), 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macroscopic examination
Statistics:
None

Results and discussion

Effect levelsopen allclose all
Sex:
female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
no deaths
Clinical signs:
During the first hours reduced spontaneous activity, and after 2-4 hours hunched posture and diarrhea with stained feces were observed. No clinical signs were noted at 1 day after administration or later.
Body weight:
male: increase of body weight after 14 days 43-51%
female: increase of body weight after 14 days 14-26%
Gross pathology:
No macroscopic findings at scheduled necropsy.

Applicant's summary and conclusion

Conclusions:
67/548/EEC: Acute oral toxicity: no classification warranted
1272/2008/EC: Acute oral toxicity: no classification warranted

The test item (Pigment Red 112) did not cause any mortality or significant clinical signs or necropsy findings after single oral gavage administration to male and female rats at 5000 mg/kg bw in a OECD guideline and GLP compliant study. The LD50 (male/female rat) was greater than 5000 mg/kg body weight.