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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 supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
October 19, 1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Remarks:
The endpoint was evaluated by means of Read Across approach. The reliability of the source study report is 2. Further information was attached at section 13

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Reference substance name:
Acid Red 418:1 - Similar Substance 01
IUPAC Name:
Acid Red 418:1 - Similar Substance 01
Test material form:
not specified

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Winkelmann
- Age at study initiation: 9 weeks old (Male), 14 weeks old (female)
- Weight at study initiation:
male: 161 - 175 g
female: 152 - 161 g
- Fasting period before study: 16 hours before
- Housing: group of 5 rats were housed in Makrolon cage type III with dust-free wood pellets
- Diet: Altromin R 1324, ad libitum.
- Water: tap water ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±1.5 °C
- Humidity (%):60 ± 5%
- Photoperiod (hrs dark / hrs light): 12 hours cycle dark light from 7:00 to 19:00

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 20 ml/kg
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5 per sex per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: twice a day
- Necropsy of survivors performed: yes

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD0
Effect level:
ca. 5 000 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 3 900 mg/kg bw
Based on:
act. ingr.
Mortality:
no mortality observed
Clinical signs:
no clinical signs observed

Applicant's summary and conclusion

Interpretation of results:
other: CLP criteria not met
Conclusions:
LD50 > 5000 mg/kg bw (3900 mg/kg bw based on active ingr.).
Executive summary:

The substance has been tested for acute toxicity by oral route to male and female Wistar rats. The LD50 was greater than 5000 mg/kg bw (3900 mg/kg bw based on active ingredient) for male and female rats.
There are no signs of intoxication.