Registration Dossier

Toxicological information

Acute Toxicity: dermal

Currently viewing:

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
data is from secondary source

Data source

Referenceopen allclose all

Reference Type:
secondary source
Title:
OPINION ON Basic Red 51 COLIPA n° B116
Author:
Scientific Committee on Consumer Products – SCCP
Year:
2011
Bibliographic source:
Scientific Committee on Consumer Products – SCCP, COLIPA n° B116, during the 10th plenary meeting of 22 March 2011
Reference Type:
secondary source
Title:
OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING BASIC RED 51
Author:
Scientific Committee on Consumer Products – SCCP
Year:
2003
Bibliographic source:
Scientific Committee on Consumer Products – SCCP, during the 25th plenary meeting of 20 October 2003

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Principles of method if other than guideline:
Acute dermal toxicity study of Basic Red 51 (77061-58-6) was performed in rats according to the OECD guideline 402(acute dermal toxicity).
GLP compliance:
not specified
Test type:
other: no data available
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (IUPAC name): 2-[[4-(Dimethylamino)phenyl]azo]-1,3-dimethyl-1H-imidazolium chloride
- Common name: Basic Red 51
- Molecular formula: C13H18N5.Cl
- Molecular weight: 279.773 g/mol
- Smiles notation: c1([n+](ccn1C)C)\N=N\c1ccc(cc1)N(C)C.[ClH-]
- InChl: 1S/C13H18N5.ClH/c1-16(2)12-7-5-11(6-8-12)14-15-13-17(3)9-10-18(13)4;/h5-10H,1-4H3;1H/q+1;/p-1
- Substance type: Organic
Specific details on test material used for the study:
- Name of test material (as cited in study report):Basic Red 51
- Molecular formula :C13H18N5.Cl
- Molecular weight :279.773 g/mol
- Substance type:organic
- Physical state:Blue to dark violet powder containing lumps
- Purity :97.2%
- Impurities (identity and concentrations):2.8%

Test animals

Species:
rat
Strain:
other: Crl:CD (SD)IGS BR
Sex:
male/female
Details on test animals and environmental conditions:
No data available

Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: distilled water
Details on dermal exposure:
TEST SITE
- Area of exposure: It was applied to the clipped area as a thin uniform layer from scapula to iliac crest and half way down the flank on each side of the animal’s back.

Details on exposure:
VEHICLE
- Concentration in vehicle:2000 mg/kg bw
- Justification for choice of vehicle: Test substance was moistened in distilled water
DOSAGE PREPARATION (if unusual): The test material was moistened with distilled water.
Duration of exposure:
Duration of exposure :24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
Total:20 animals
0 mg/kg bw:10 males and 10 females
2000 mg/kg bw:10 males and 10 females
Control animals:
yes
Details on study design:
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: All animals were examined for clinical signs of ill health or mortality immediately post-dose and approximately 1, 2.5 and 4 hours post-dose, and daily thereafter.
- Frequency of weighing:Body weights were recorded pre-dose on the day of dosing (Day 0), and on Days 7 and 14, and prior to sacrifice on Day 15 (fasted)
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs,body weight, organ weights
Statistics:
No data available

Results and discussion

Preliminary study:
No data available
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality was observed at dose 2000 mg/kg bw
Mortality:
No mortality was observed at dose 2000 mg/kg bw
Clinical signs:
Signs of clinical toxicity included chromodacryorrhea and/or red nasal discharge. Findings were first noted 4 hours post-dose and were resolved by Day 2.
Signs of dermal irritation included desquamation (slight scaling) in all males on Day 3 and in one male and one female on Day 7. There were no signs of dermal irritation at any observation interval in any of the remaining animals.
Additional dermal irritation readings were performed for each animal on Days 3, 7, 10, and 14.
There were also minor systemic effects.
Body weight:
All animals gained weight during the course of the study.
Gross pathology:
A curtailed gross examination of the cervical, thoracic and abdominal viscera was performed.
No visible lesions were noted in any of the animals at necropsy.
Other findings:
no data available

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
The LD50 value was considered to be >2000 mg/kg bw,when 10 males and 10 females Crl:CD (SD)IGS BR rats were occlusively treated with Basic Red 51 (77061-58-6) by dermal application.
Executive summary:

In acute dermal toxicity study,10 males and 10 females Crl:CD (SD)IGS BR rats were occlusively treated with Basic Red 51(77061-58-6)in the concentration of 2000 mg/kg bw by dermal application following 14 days of observation period. The test material was moistened with distilled water.The untreated skin of each animal served as the control.The hair was clipped the day prior to the experiment. It was applied to the clipped area as a thin uniform layer from scapula to iliac crest and half way down the flank on each side of the animal’s back. The area was occluded for 24 hrs.The initial dermal irritation was scored and recorded 30 minutes after bandage removal on Day 1.No mortality was observed in treated rats at dose 2000 mg/kg bw.Signs of clinical toxicity included chromodacryorrhea and/or red nasal discharge. Findings were first noted 4 hours post-dose and were resolved by Day 2. Signs of dermal irritation included desquamation (slight scaling) in all males on Day 3 and in one male and one female on Day 7. There were no signs of dermal irritation at any observation interval in any of the remaining animals.All animals gained weight during the course of the study. No visible lesions were noted in any of the animals at necropsy.Therefore, LD50 value was considered to be >2000 mg/kg bw,when rats were treated with Basic Red 51(77061-58-6)by dermal application.