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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 from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
2000
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Peer reviewed authority database (Peer review was conducted by a Japanese toxicological expert group at March 5, 2001. However, detailed information were not available). Furthermore test results were taken for the OECD SIDS Intital assessment report for C.I. Pigment Yellow 53.

Data source

Referenceopen allclose all

Reference Type:
other: Peer reviewed database
Title:
Unnamed
Year:
2002
Reference Type:
other: OECD Substance initial assessment report (SIAR)
Title:
SIDS Initial Assessment Report For SIAM 15 (Oct. 2002)
Author:
OECD
Year:
2002
Bibliographic source:
OECD SIDS Initial Assessment Report, C.I. Pigment Yellow 53, CAS No. 8007-18-9

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
GLP compliance:
yes
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Purity: 100%
- Lot/batch No.: 4879

Test animals

Species:
rat
Strain:
other: Crj; CD(SD) IGS
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: aqueous suspension in 1 % sodium carboxymethyl cellulose
Doses:
0, 2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations : at least once daily
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortalities were observed.
Clinical signs:
No clinical signs of toxicity were observed. The feces were yellow within one day after administration.
Body weight:
The body weights of treated animals were comparable to the control group throughout the study period.
Gross pathology:
No gross internal lesions were observed during necropsy.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU