Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 202-180-8 | CAS number: 92-70-6
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Limited number of animals. Apart from that, study conducted according to GLP and OECD 406 test guideline. No information on positive controls.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- of 1981
- Deviations:
- yes
- Remarks:
- Number of animals lower than recommended in OECD TG 406.
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- LLNA was not established in 1988
Test material
- Reference substance name:
- 3-hydroxy-2-naphthoic acid
- EC Number:
- 202-180-8
- EC Name:
- 3-hydroxy-2-naphthoic acid
- Cas Number:
- 92-70-6
- Molecular formula:
- C11H8O3
- IUPAC Name:
- 3-hydroxynaphthalene-2-carboxylic acid
- Details on test material:
- - Name of test material (as cited in study report): BONS
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright-White Hoe: DHPK(SPFLac)
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG, breeding colony
- Weight at study initiation: mean: 316 g, min: 280 g, max: 362 g
- Housing: groups of five, in macrolon cages
- Diet (e.g. ad libitum): guinea pig diet, ERKA 8300
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/-3
- Humidity (%): 50 +/- 20
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: 1st induction (intradermal): paraffin; 2nd induction (epicutaneous): vaseline; challenge: vaseline
- Concentration / amount:
- 1st induction (intradermal): 2 % test material in paraffin and in 50% Freund's Adjuvant,
2nd induction (epicutaneous): 0.25 % test material in vaseline
Challenge (epicutaneous): 0.25 % test material in vaseline
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: 1st induction (intradermal): paraffin; 2nd induction (epicutaneous): vaseline; challenge: vaseline
- Concentration / amount:
- 1st induction (intradermal): 2 % test material in paraffin and in 50% Freund's Adjuvant,
2nd induction (epicutaneous): 0.25 % test material in vaseline
Challenge (epicutaneous): 0.25 % test material in vaseline
- No. of animals per dose:
- dose group: 10
control group: 5 - Details on study design:
- 1st Induction on day 1
2nd Induction on day 9
Challenge on day 22
1st reading on day 24
2nd reading on day 25 - Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.5 ml of 0.25% test material in vaseline
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0.5 ml of 0.25% test material in vaseline. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5 ml of 0.25% test material in vaseline
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.5 ml of 0.25% test material in vaseline. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 0.5 ml of 0.25% test material in vaseline
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 0.5 ml of 0.25% test material in vaseline. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 0.5 ml of 0.25% test material in vaseline
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 0.5 ml of 0.25% test material in vaseline. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- There was no indication of any sensitising effect of the test substance in the present study.
- Executive summary:
The test item was tested for skin sensitisation according to OECD Guideline 406 (Maximization Test) and in compliance with GLP. The first inductions was performed by intradermal injections of 2 % test material in paraffin and in 50% Freund's Adjuvant into the scapular region on day 1. On day 9 the second induction and on day 22 the challenge were performed by occlusive, epicutaneous administration of 0.25 % test material in vaseline. There was no indication of any sensitising effect of the test substance in the present study. None of the animals showed any erythema or edema reactions at 48 and 72 h post challenge. Therefore, the test substance was considered to be "not sensitising". Signs of systemic toxicity were not evident during the study and bodyweight was not adversely affected by treatment with the test substance.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
