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EC number: 267-956-0 | CAS number: 67953-76-8
Endpoint summary
Administrative data
Description of key information
There are no in vitro or in vivo data on skin sensitisation for HEDP-xK, therefore good quality data are read-across from the category member HEDP (2-3Na).
In a guinea-pig maximisation study (reliability score 2), not conducted according to any OECD Test Guideline and pre-GLP, HEDP (2 -3Na) is not sensitising to the skin of guinea pigs (Henkel, 1982).
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- 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
- Reason / purpose for cross-reference:
- read-across: supporting information
- Principles of method if other than guideline:
- Method: variation of Magnusson and Kligman method
- GLP compliance:
- no
- 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
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Not specified
- Females nulliparous and non-pregnant: Not specified
- Microbiological status of animals, when known: Not specified
- Age at study initiation: Not specified
- Weight at study initiation: Median body weight for the test group: 403 grams; Median body weight for the control group: 402 grams. No further details available.
- Housing: Not specified
- Diet: Not specified
- Water: Not specified
- Acclimation period: Not specified
- Indication of any skin lesions: Not specified
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not specified
- Humidity (%): Not specified
- Air changes (per hr): Not specified
- Photoperiod (hrs dark / hrs light): Not specified
- IN-LIFE DATES: Not specified - 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 animals for the test group and 20 animals for the control group.
- Details on study design:
- RANGE FINDING TESTS: Not specified
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: Initially, 6 injections were performed (symmetrically and simultaneously). A week later, a topical induction was performed.
- Exposure period: A week
- Test groups: Not specified
- Control group: Not specified
- Site: Around the shoulder blades
- Frequency of applications: Initially, 6 injections were performed simultaneously followed by a topical induction a week later consisting of a 5% mixture in Vaseline, under a 2 x 4 cm piece of filter paper.
- Duration: The occlusive covering covered the site of topical induction for 48 hours
- Type of covering: Occlusive covering of watertight plastic and an elastic bandage.
- Concentrations:
2 x 0.1 ml Freund's Adjuvant (foremost two sites)
2 x 0.1 ml 5% aqueous solution of test substance (middle two sites)
2 x 0.1 ml Mixture (1:1) of 5% aqueous solution of test substance and Freund's Adjuvant (hindmost two sites).
As the concentration of the test substance is not clear, there is no evidence that this induction dose was irritating.
B. CHALLENGE EXPOSURE
- No. of exposures: One
- Day(s) of challenge: 14 days
- Exposure period: Appearing to be 21 hours (not clearly stated). 21 hours after the challenge, the area was re-shaved and remaining test substance was carefully removed with ether.
- Test groups: Not specified
- Control group: Not specified
- Site: 5 x 5 cm area around the flanks
- Type of covering: A 2 x 2 cm piece of filter paper, no occlusive covering appears to have been applied at this stage.
- Concentrations: 25 % mixture in Vaseline
- Evaluation (hr after challenge): 3 hours
OTHER: Areas were shaved or re-shaved prior to the application of the test substance.
1st application: Induction 5 % intracutaneous
2nd application: Induction 5 % occlusive epicutaneous
3rd application: Challenge 25 % semiocclusive - Positive control substance(s):
- not specified
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- No. with + reactions:
- 8
- Total no. in group:
- 20
- Clinical observations:
- erythema, grade 1 - slight redness
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- No. with + reactions:
- 5
- Total no. in group:
- 20
- Clinical observations:
- erythema, grade 1 - slight redness, reversible within 72 hours
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- No. with + reactions:
- 6
- Total no. in group:
- 20
- Clinical observations:
- erythema, grade 1 - slight redness
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Clinical observations:
- erythema, grade 1 - slight redness, reversible within 72 hours
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Reading:
- 2nd reading
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a guinea-pig maximisation study (reliability score 2), not conducted according to any OECD Test Guideline and pre-GLP, HEDP (2-3Na) is not sensitising to the skin of guinea pigs.
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:
In a guinea-pig maximisation study (reliability score 2), not conducted according to any OECD Test Guideline and pre-GLP, a test group consisting of 20 animals were exposed to an initial intradermal injection. In the induction, a 4 x 6 cm area around the shoulder blades was shaved and 6 injections made (symmetrically and simultaneously) consisting of 2 x 0.1 mL Freund's Adjuvant (foremost two sites); 2 x 0.1 mL 5% aqueous solution of test substance (middle two sites); 2 x 0.1 mL mixture (1:1) of 5% aqueous solution of test substance and Freund's Adjuvant (hindmost two sites). After one week, the same area was re-shaved and the test substance was applied as a 5% mixture in Vaseline, under a 2 x 4 cm piece of filter paper. This was covered with an occlusive covering of watertight plastic and an elastic bandage for a period of 48 hours. The dose of the test substance is unclear and consequently, there is no evidence that the induction dose was irritating.
After a further 14 days, a 5 x 5 cm area around the flanks was shaved and the test substance applied as a 25% mixture in Vaseline under a 2 x 2 cm piece of filter paper. No occlusive covering appears to have been applied at this stage. The duration of exposure appears to have been 21 hours (although unclear). A further 21 hours after the challenge, the area was re-shaved and the remaining test substance was carefully removed with ether. Responses were assessed three hours following this procedure.
Very slight erythema (grade 1) was observed in the negative control group as well as in the test group at both 24 and 48 hours. However, this was completely reversible in all animals by 72 hours. It is concluded that HEDP (2-3Na) is not sensitising to the skin of guinea pigs (Henkel, 1982).
See read-across justification in IUCLID Section 13.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the available read-across data, HEDP-xK does not require classification for skin sensitisation according to Regulation (EC) No. 1272/2008.
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