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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 05 to 24 September, 2002
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
The complete study report is not available, thus some details about test conditions are missing.

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
adopted 17 December 2001
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Acid Yellow 236
IUPAC Name:
Acid Yellow 236

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 189 - 255 g
- Fasting period before study: fasted females were used; no details about the fasting period.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
A group of three fasted females was treated with the test materia; this was followed by a further group of three fasted female animals at the same dose level.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
6 females (three animals per step)
Details on study design:
Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no deaths or signs of systemic toxicity.
Gross pathology:
No abnormalities detected.

Any other information on results incl. tables

Individual Bodyweights and Weekly Bodyweight Changes

Dose Level mg/kg Animal N. and Sex Bodyweight (g) at Day Bodyweight Gain (g) During Week
0 7 14 1 2
2000 1-0 Female 220 241 258 21 17
1-1 Female 255 299 314 44 15
1-2 Female 192 216 242 24 26
2-0 Female 206 230 246 24 16
2-1 Female 199 228 236 29 8
2-2 Female 189 220 230 31 10

Applicant's summary and conclusion

Interpretation of results:
other: not classified, according to the CLP Regulation (EC) No 1272/2008
Conclusions:
LD50 (female) > 2000 mg/kg bw
Executive summary:

The study was performed to assess the acute oral toxicity of the test material following a single oral administration in the Sprague-Dawley Crl:CD(R) (SD) IGS BR rat. The method followed the OECD Guidelines No. 423.

A group of three fasted females was treated with the test material at a dose level of 2000 m/kg bw. This was followed by a further group of three fasted female animals at the same dose level. The test material was administered orally as a suspension in distilled water. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.

There were no deaths or signs of systemic toxicity. The acute oral median lethal dose (LD50) of the test material, in the rat, was estimated as being greater than 2000 mg/kg bodyweight.

Conclusion

LD50 (female) > 2000 mg/kg bw