Hexadecyl(2-hydroxyethyl)dimethylammonium dihydrogen phosphate

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: basic information given

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Principles of method if other than guideline:

according to Magnusson and Kligman (J. Invest. Dermatol. 52, 1969); recommended in the OECD guidelines 1981 and in the EEC Directive 79/831

GLP compliance:

no

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

Test was done before implementation of the LLNA method.

Species:

guinea pig

Strain:

other: Pirbright white

Sex:

male/female

Details on test animals and environmental conditions:

- Acclimatization period: 12 days
- Age at study start: about 10 weeks
- Body weights between 292 and 480 g
- The animals were housed individually in Macrolon cages (type 3), assigned to the different groups by means of random numbers generated by the random number generator incorporated in the Hewlett-Packard desk computer, identified with individual ear tags, kept at a constant room ternperature of 20 +/- 1°C, at a relative humidity of 50 +/- 10% and on a 14 hours light cycle day. A 14 hours light cycle day is necessary to eliminate seasonal variation because the animal rooms are not totally protected from natural sunlight.
- The animals received ad libitum standard guinea-pigs pellets and fresh water, supplemented with fresh carrots.

Route:

other: intradermal and epidermal

Vehicle:

other: induction: physiological saline; challenge: soft white petrolatum (vaseline)

Concentration / amount:

- Induction: intradermal 5% test substance, epidermal 10% test substance
- Challenge: epidermal 1% test substance

Route:

other: epidermal

Vehicle:

other: induction: physiological saline; challenge: soft white petrolatum (vaseline)

Concentration / amount:

- Induction: intradermal 5% test substance, epidermal 10% test substance
- Challenge: epidermal 1% test substance

No. of animals per dose:

10 males and 10 females

Details on study design:

- Induction, intradermal application: Two intraderrnal injections (0.1 ml per injection) were made into the neck of the guinea-pigs with a mixture of adjuvant and saline, with the test compound in saline and with the test compound in the adjuvant saline mixture.
- Induction, epiderinal application: One week later the test compound was incorporated in vaseline and applied on a filterpaper patch to the neck of the animals (occlusive administration for 48 hours).
- Challenge: Two weeks after the epidermal induction application the animals were tested on the flank with 1% test compound in vaseline and the vehicle alone (24 h occlusive application). Twenty-four hours after removing the dressings the challenge reactions were graded according to the Draize scoring scale. The application sites were chemically depilated 3 hours before examination. A second evaluation is made 48 hours after removing the dressings. The concentrations of the test compound for induction and challenge periods were determined on separate animals. 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 (at least 10 animals) to control the maximal subirritant concentration of the test compound in adjuvant treated animals.

Positive control substance(s):

yes

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

5 and 10%

No. with + reactions:

0

Total no. in group:

20

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5 and 10%. No with. + reactions: 0.0. Total no. in groups: 20.0.

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

5 and 10%

No. with + reactions:

0

Total no. in group:

20

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5 and 10%. No with. + reactions: 0.0. Total no. in groups: 20.0.

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

According to these test results the test item can be classified as "no skin sensitizer" in the GPMT on guinea pigs.

Executive summary:

The skin sensitising potential of the test item was asessed using the guinea pig maximisation test. The test was performed with 10 male and 10 females guinea pigs per group. For the induction two intradermal injections (0.1ml) were done and one week later the epidermal induction was done by an occlusive application of the test substance diluted in vaseline for 48 hours. Two weeks after the epidermal induction the challenge was done with an application on the flank wit 1% in vaseline ( 24 h occlusive dressing). Twenty-four hours after removal of the patch, the reactions were graded according to the Draize scoring scale. A second evaluation is made 48 hours after removal. 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. None of the animals showed any signs of skin irritation or skin sensitisation.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

The skin sensitising potential of the test item was asessed using the guinea pig maximisation test. The test was performed with 10 male and 10 females guinea pigs per group. For the induction two intradermal injections (0.1ml) were done and one week later the epidermal induction was done by an occlusive application of the test substance diluted in vaseline for 48 hours. Two weeks after the epidermal induction the challenge was done with an application on the flank wit 1% in vaseline ( 24 h occlusive dressing). Twenty-four hours after removal of the patch, the reactions were graded according to the Draize scoring scale. A second evaluation is made 48 hours after removal. 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. None of the animals showed any signs of skin irritation or skin sensitisation.

The information available on the skin sensitisation potential of the test item show no need for a classification of the test item concerning skin sensitisation.

Migrated from Short description of key information:
GPMT: not sensitising

Justification for selection of skin sensitisation endpoint:
Reliable and well documented study which is the basis for classification.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for skin sensitisation under Directive 67/548/EEC, as amended for the 31st time in Directive2009/2/EC.

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

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for skin sensitisation under Regulation (EC) No 1272/2008, as amended for the fifth time in Directive EC 944/2013.