Registration Dossier

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
Reference
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:
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 group
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 group
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

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

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.
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