Registration Dossier

Administrative data

Description of key information

No data are available for HEDP potassium salt. Therefore, data were read-across from HEDP acid.

In a guinea-pig maximisation study (Henkel, 1982), which pre-dated current GLP requirements, HEDP-H/etidronic acid 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:
experimental study
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
Principles of method if other than guideline:
Method: other: variation of Magnusson and Kligman method
GLP compliance:
no
Remarks:
Study was conducted prior to 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 Guinea Pig Maximisation 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
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
No. with + reactions:
8
Total no. in group:
20
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
No. with + reactions:
5
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
negative control
No. with + reactions:
6
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
negative control
No. with + reactions:
2
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Group:
positive control
Remarks on result:
other: No information on positive control

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, sodium salt of HEDP 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

Justification for classification or non-classification

Based on available read-across data for HEDP acid, potassium salts of HEDP do not require classification for skin sensitisation according to Regulation (EC) No 1272/2008.