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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 201-607-5 | CAS number: 85-44-9
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: No solvent control, details of the reading not given, number of animals not given, poor documentation
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- Comparison of local lymph node assay with the guinea-pig maximization test for the detection of a range of contact allergens
- Author:
- Basketter DA, Scholes EW (1992). Comparison of local lymph node assay with the guinea-pig maximization test for the detection of a range of contact allergens. Fd. Chem. Toxicol. 30, 65-69.
- Year:
- 1 992
- Bibliographic source:
- Fd. Chem. Toxicol. 30, 65-69.
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Principles of method if other than guideline:
- Guinea pigs were treated by a series of 6 intradermal injections in the shoulder region to induce sensitization. After 6-8 days, sensitization was boosted by a 48 h occluded patch placed over the injection site. 12-14 days later, the animals were challenged on the flank by a 24 h occluded patch at the maximum non-irritant concentration. Challenge sites were scored for erythema and edema 24 and 48 h after removal of the patches
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Published study (1992). At this time an OECD guideline for a LLNA was not available.
Test material
- Reference substance name:
- Phthalic anhydride
- EC Number:
- 201-607-5
- EC Name:
- Phthalic anhydride
- Cas Number:
- 85-44-9
- Molecular formula:
- C8H4O3
- IUPAC Name:
- 1,3-dihydro-2-benzofuran-1,3-dione
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- not specified
- Details on test animals and environmental conditions:
- no data
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: acetone /polyethylene glycol 400 = 70:30
- Concentration / amount:
- induction injection: 0.1%
induction patch: 25%
challenge patch: 10%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: acetone /polyethylene glycol 400 = 70:30
- Concentration / amount:
- induction injection: 0.1%
induction patch: 25%
challenge patch: 10%
- No. of animals per dose:
- no data
- Details on study design:
- 1st application: Induction 0.1 % intracutaneous
2nd application: Induction 25 % occlusive epicutaneous
3rd application: Challenge 10 % occlusive epicutaneous
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- other: Not specified
- Group:
- test chemical
- Dose level:
- Not specified
- Remarks on result:
- other: 90 % of the tested guinea pigs were judged to be positive. Classification: extreme sensitizing (no further details given)
- Reading:
- other: Not specified
- Group:
- negative control
- Remarks on result:
- other: Dextran, 10% in challenge experiment
- Reading:
- other: Not specified
- Group:
- positive control
- Remarks on result:
- other: m-Aminophenol, 5% in challenge
Any other information on results incl. tables
90 % of the tested guinea pigs were judged to be positive. Classification: extreme sensitizing (no further details given).
Applicant's summary and conclusion
- Interpretation of results:
- Category 1A (indication of significant skin sensitising potential) based on GHS criteria
- Executive summary:
Guinea pigs were treated by a series of 6 intradermal injections in the shoulder region to induce sensitization. After 6-8 days, sensitization was boosted by a 48 h occluded patch placed over the injection site. 12-14 days later, the animals were challenged on the flank by a 24 h occluded patch at the maximum non-irritant concentration. Challenge sites were scored for erythema and edema 24 and 48 h after removal of the patches. 90% of the animals were judged to be positive, resulting in the overall assessment of extremely sensitizing.
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.
