Amines, C12-14-alkyl, C6-10-alkyl phosphates

Skin sensitisation

Administrative data

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:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Materials and methods

Test guideline

Qualifier:

according 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:

yes

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

Test material

Test material information

Constituent 1

Reference substance name:

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

EC Number:

279-632-6

EC Name:

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

Cas Number:

80939-62-4

Molecular formula:

na (UVCB)

IUPAC Name:

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

Test material form:

liquid: viscous

In vivo test system

Test animals

Species:

guinea pig

Strain:

other: Pirbright White Strain

Sex:

male/female

Details on test animals and environmental conditions:

The test was performed on 10 male and 10 female guinea pigs per
group weighing between 313 and 401 g ( 'vlo weeks old). 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 temperature of 20 + 1 C, at a relative
humidity of 50 + 10% and on a 14 hours light cycle day. The
animals received ad libitum standard guinea pig pellets -
NAFAG No. 830, Gossau SG - and fresh water, supplemented with
fresh carrots.
The guinea pig is the animal of choice for sensitization studies

Study design: in vivo (non-LLNA)

Induction

Route:

intradermal

Vehicle:

other: Adjuvant saline mixture = 50 % adjuvant complete Freund (Difco, Michigan), 50 % physiological saline

Concentration / amount:

0.1 ml

Day(s)/duration:

First and second induction week

Challenge

No.:

#1

Route:

epicutaneous, occlusive

Vehicle:

other: vaseline

Concentration / amount:

Induction: 10% in vaseline
Challenge: 30% in vaseline

Day(s)/duration:

1 d

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:

The test was performed on 10 male and 10 female guinea pigs per
group weighing between 313 and 401 g ( 'vlo weeks old). 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 temperature of 20 + 1 C, at a relative
humidity of 50 + 10% and on a 14 hours light cycle day. The
animals received ad libitum standard guinea pig pellets -
NAFAG No. 830, Gossau SG - and fresh water, supplemented with
fresh carrots.
The guinea pig is the animal of choice for sensitization studies.
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.

Challenge controls:

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 (Appendix).
The application sites were chemically depilated before examination
(Veet , '^ 5 minutes)

Positive control substance(s):

not specified

Results and discussion

Positive control results:

not specified

In vivo (non-LLNA)

Results

Results 1

Key result

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

Results 2

Key result

Reading:

1st reading

Hours after challenge:

24

Group:

negative control

Dose level:

vehicle and adjuvant

No. with + reactions:

0

Total no. in group:

20

Clinical observations:

none

Results 3

Key result

Reading:

1st reading

Group:

positive control

Remarks on result:

other: no information on a positive control is available.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Only two animals of the test group reacted after the challenge application of the test substance. The sensitizing potential of the test substance
can therefore be considered to be very low and the test substance is considered to be a non-sensitizer.

Executive summary:

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.