Amines, C11-14-branched alkyl, monohexyl and dihexyl phosphates

Endpoint summary

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:

14.06.1982 - 14.07.1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Comparable to guideline study with restrictions (no details on the test substance; no details of the control group; during induction, the test substance was applied on filter patches after an intracutaneous injection of an adjuvant saline mixture; only one reading after challenge at 24 hours).

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Deviations:

yes

Remarks:

(no details on the test substance; no details on the control group; as first induction step, the test substance was applied on filter patches after an intracutaneous injection of an adjuvant saline mixture; only one reading after challenge at 24 hours)

GLP compliance:

no

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

A valid guinea pig study is available peformed before the LLNA protocol was established

Species:

guinea pig

Strain:

other: Pirbright White Strain

Sex:

male/female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Ivanovas, Germany
- Age at study initiation: about 10 weeks
- Weight at study initiation: 313-401 g
- Housing: individually in Macrolon cages (type 3)
- Diet (ad libitum): standard guinea pig pellets - NAFAG No. 830
- Water (ad libitum): fresh water, supplemented with fresh carrots
- Acclimation period: 11 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1
- Humidity (%): 50 +/- 1
- Photoperiod (hrs dark / hrs light): 10/14

Route:

intradermal and epicutaneous

Vehicle:

other: vaseline

Concentration / amount:

10 % of the test substance in vaseline at intradermal/epicutaneous induction; 30 % at challenge

Route:

epicutaneous, occlusive

Vehicle:

other: vaseline

Concentration / amount:

10 % of the test substance in vaseline at intradermal/epicutaneous induction; 30 % at challenge

No. of animals per dose:

20 animals (10 males/10 females) in the test group, no details concerning the control group

Details on study design:

RANGE FINDING TESTS: The concentrations of the test compound for induction and challenge periods were determined on separate animals.

A. MAIN STUDY
Test Group:
First induction week: 0.1 ml of a freshly prepared adjuvant saline mixture was injected intracutaneously at 4 sites on the animal's neck. The test compounds were applied on filter patches (2 x 4 cm) to the epidermis over the injection sites for 24 hours under an occlusive dressing.

Second induction week: The test compound was applied in the same way as during the first week for 48 hours occlusively.

Challenge: After a rest period of 14 days the compound was applied on filter paper patches (2 x 2 cm) to an untreated flank skin of the animals for 24 hours epidermal occlusively.

Twenty four hours after removing the dressings the challenge reactions were graded according to the Draize scoring scale.

Control group:
A control group was treated with adjuvant and the vehicle during the induction period. During the challenge period the group was treated with the vehicle as well as with the test compound to control the maximal subirritant concentration of the test compound in adjuvant treated animals.

Positive control substance(s):

no

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

30 %

No. with + reactions:

2

Total no. in group:

20

Clinical observations:

two male animals showed very slight erythema (grade 1); results of the control group were not given

Remarks on result:

other: see Remark

Remarks:

Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 30 %. No with. + reactions: 2.0. Total no. in groups: 20.0. Clinical observations: two male animals showed very slight erythema (grade 1); results of the control group were not given.

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Skin sensitisation

In a Guinea pig mximization study, Pirgbright White guinea pigs (10 male and 10 female animals) were treated with the test substance. Intradermal induction was performed as follows: 0.1 ml of a freshly prepared adjuvant saline mixture was injected intracutaneously at 4 sites on the animal's neck. The test compounds were applied on filter patches (2 x 4 cm, 10% in vaseline) to the epidermis over the injection sites for 24 hours under an occlusive dressing. In the second induction week, the test compound was applied on filter patches (2x2 cm, 10% in vaseline) to an untreated flank skin of the animals for 24 hours epidermal occlusively. Challenge: After a rest period of 14 days the compound was applied on filter paper patches (2 x 2 cm, 30% in vaseline) to an untreated flank skin of the animals for 24 hours epidermal occlusively. 24 hours after removing the dressings the challenge reactions were graded according to the Draize scoring scale: 2 of 20 (10%) showed very slight edema (grade 1) after 24 hours.

Migrated from Short description of key information:
The skin sensitizing potential fo the test susbtance was assessed in a Guinea pig mximization test (Ciba-Geigy, 1982). It was concluded that the test substance does not show a skin sensitizing effect in the Guinea Pig maximization test under the test conditions chosen.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available experimental test data is reliable and suitable for the purpose of classification under Directive 67/548/EEC. Based on the data, classification for sensitisation is not warranted under Directive 67/548/EEC.

 

Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for the purpose of classification under Regulation (EC) No.1272/2008. Based on the data, classification for sensitisation is not warranted under Regulation (EC) No.1272/2008.