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Diss Factsheets

Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
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 the safety assessment report

Data source

Reference
Reference Type:
secondary source
Title:
OPINION ON PHENYLBENZIMIDAZOLE SULFONIC ACID AND ITS SALTS
Author:
HEALTH AND CONSUMER PROTECTION DIRECTORATE GENERAL
Year:
2006
Bibliographic source:
OPINION ON PHENYLBENZIMIDAZOLE SULFONIC ACID AND ITS SALTS- SCCP/1056/06

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Principles of method if other than guideline:
The skin sensitisation study was conducted on guinea pigs to determine its sensitisation potential of 2-phenyl-1H-benzimidazole-5-sulphonic acid.
GLP compliance:
no
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
not specified

Test material

Constituent 1
Reference substance name:
Ensulizole
IUPAC Name:
Ensulizole
Constituent 2
Reference substance name:
2-phenyl-1H-benzimidazole-5-sulphonic acid
EC Number:
248-502-0
EC Name:
2-phenyl-1H-benzimidazole-5-sulphonic acid
Cas Number:
27503-81-7
IUPAC Name:
2-phenyl-1H-benzimidazole-5-sulfonic acid
Test material form:
solid
Details on test material:
- IUPAC name:Phenylbenzimidazole Sulfonic Acid
- Molecular formula: C13H10N2O3S
- Molecular weight: 274.299g/mol
- Substance type: organic
-Physical state: solid
Specific details on test material used for the study:
- Name of test material (as cited in study report): HR 92/103089 (Phenylbenzimidazole Sulfonic Acid )
- Molecular formula : C13H10N2O3S
- Molecular weight: 274.299g/mol
- Substance type: organic
- Physical state: solid

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
not specified
Details on test animals and environmental conditions:
No data available.

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal
Vehicle:
arachis oil
Concentration / amount:
INDUCTION PHASE: INTRADERMAL
•0.1ml Freund’s complete adjuvant in Water
•1% Phenylbenzimidazole Sulfonic Acid (w/v) in arachis oil
•Freund’s + 1% of Phenylbenzimidazole Sulfonic Acid (w/v) in arachis oil (1:1)

TOPICAL
•0.2 – 0.3 ml 50% Phenylbenzimidazole Sulfonic Acid (w/v) in arachis oil
Day(s)/duration:
Intradermal-1 week ; Topical-48 hours
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
other: Epicutaneous
Vehicle:
arachis oil
Concentration / amount:
0.1-0.2 ml 25 and 10% of Phenylbenzimidazole Sulfonic Acid (w/v) in arachis oil
Day(s)/duration:
21 days
No. of animals per dose:
30 (Test groups: 20 ; Control group: 10)
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures:1
- Exposure period: 1 week
- Topical: 48 hours
- Test groups: 20
- Control group: 10
- Site: intradermal : three separate sites.
- Duration: Intradermal-1 week
Topical-48 hours
- Concentrations:
•0.1ml Freund’s complete adjuvant in Water
•1% Phenylbenzimidazole Sulfonic Acid (w/v) in arachis oil
•Freund’s + 1% of Phenylbenzimidazole Sulfonic Acid (w/v) in arachis oil (1:1)

TOPICAL
•0.2 – 0.3 ml 50% Phenylbenzimidazole Sulfonic Acid (w/v) in arachis oil

After 1 week, a single topical application of 0.2 – 0.3 ml HR 92/103089 50% w/w in arachis oil under occlusion for 48 hours.

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: On day 21
- Exposure period: No Data Available
- Test groups: 20
- Control group: 10
- Site: No Data Available
- Concentrations: 0.1-0.2 ml 25 and 10% of Phenylbenzimidazole Sulfonic Acid (w/v) in arachis oil
- Evaluation (hr after challenge): No data available.
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Group:
test chemical
Dose level:
0.1-0.2 ml HR 92/103089 25 and 10% w/w in arachis oil
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No reactions were observed.
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
other: not sensitising
Conclusions:
The test material Ensulizole (CAS No: -27503-81-7) was observed to be not sensitising to guinea pigs skin.
Executive summary:

The skin sensitization studyofEnsulizole(CAS No: -27503-81-7)was performed inDunkin Hartleyguinea pigs to observed its sensitizing efficacy.

 

In induction phase 20 animals in test group and 10 animals in negative controls were used. Animals were induced with intradermal injections of 0.1ml Freund’s complete adjuvant in water, Phenylbenzimidazole Sulfonic Acid 1% w/v in arachis oil, and Freund’s + Phenylbenzimidazole Sulfonic Acid 1% w/v in arachis oil (1:1) into three separate sites.After 1 week, a single topical application of0.2 – 0.3 ml Phenylbenzimidazole Sulfonic Acid 50% w/w in arachis oilunder occlusion for 48 hours was applied.

 

 On day 21 animals were challenged with 0.l-0.2 ml Phenylbenzimidazole Sulfonic Acid 25 and 10% w/w in arachis oil.

 

Since there was no evidence of any skin reaction, the test materialEnsulizole/Phenylbenzimidazole Sulfonic Acid (CAS No: -27503-81-7) can be concluded as not sensitizing to guinea pigs.