Registration Dossier
Registration Dossier
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EC number: 223-267-7 | CAS number: 3794-83-0
Endpoint summary
Administrative data
Description of key information
In a guinea-pig maximisation study (Henkel, 1982), not conducted to GLP, sodium salt of HEDP was not sensitising to the skin.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- August 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- according to guideline
- Guideline:
- other: Magnusson and Kligman Method
- Principles of method if other than guideline:
- Variation of Magnusson and Kligman method
- GLP compliance:
- no
- Remarks:
- pre GLP
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- An LLNA study was not performed because there is an existing reliable study for skin sensitisation using the Magnusson and Kligman method test method.
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- female
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: water, Freund's Adjuvant (intradermal induction) and Vaseline (topical induction and challenge)
- Concentration / amount:
- 5% induction, 25% challenge
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- other: water, Freund's Adjuvant (intradermal induction) and Vaseline (topical induction and challenge)
- Concentration / amount:
- 5% induction, 25% challenge
- No. of animals per dose:
- 20 test and 20 controls
- Details on study design:
- 1st application: Induction 5 % intracutaneous
2nd application: Induction 5 % occlusive epicutaneous
3rd application: Challenge 25 % semiocclusive - Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 8
- Total no. in group:
- 20
- Clinical observations:
- erythema grade 1
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 5
- Total no. in group:
- 20
- Clinical observations:
- erythema grade 1
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 6
- Total no. in group:
- 20
- Clinical observations:
- grade 1 erythema
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Clinical observations:
- grade 1 erythema
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a guinea-pig maximisation study (reliability score 2), not conducted to GLP, the test substance was not sensitising to the skin.
Reference
TEST SUBSTANCE GROUP RESPONSES:
24 hours: 8 animals (erythema: grade 1 - slight redness)
48 hours: 5 animals (erythema: grade 1 - slight redness)
72 hours: 0 animals displaying symptoms
CONTROL GROUP RESPONSES:
24 hours: 6 animals (erythema: grade 1 - slight redness)
48 hours: 2 animals (erythema: grade 1 - slight redness)
72 hours: 0 animals displaying symptoms
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The most reliable study was selected as the key study.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
Based on available data sodium salt of HEDP does not require classification for skin sensitisation.
Justification for classification or non-classification
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.
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