3-methyl-5-phenylpentanol

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:

Not reported

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The study was performed in line with good scientific principles and reported to a reasonable standard. The method employed (Magnusson and Kligman (1969) The Identification of Contact Allergens by Animal Assay – The Maximistation Test. J. Invest. Dermatol. Vol. 52, No. 3 p. 268-276) was an early method, which the modern OECD 406 is based on. The results of the study are considered to be suitable for assessing the test substance. No positive controls were used in the study, however the reactions noted with Freund's adjuvant indicate that the immune system of the test animals was funcitonal. As no sensitising reactions whatsoever were noted with the test animals, the low numbers in the test group were not considered to affect the integrity of the results.

Qualifier:

no guideline followed

Principles of method if other than guideline:

Male Hartley guinea pigs were exposed to the test substance, either mixed with an adjuvant or with the vehicle used in the study. The animals were induced twice, the first induction was by intradermal injection. Three injections were made in the shoulder region, with the adjuvant alone, the test substance in the vehicle and the test substance in adjuvant. Six days after the first induction, the test site was treated with 10 % Sodium Lauryl Sulphate. 24 hours after which, the animals were exposed to the test material again by means of a topical application (occluded). Two weeks after the final induction phase, the animals were challenged topically. After 24 hours the patch was removed and the animals were assessed for reactions 24 hours after patch removal and again 24 hours after the first observation.

The method was that of Magnusson B and Kligman AM (1969) The Identification of Contact Allergens by Animal Assay – The Maximisation Test. J. Invest. Dermatol. Vol. 52, No. 3 p. 268-276.

GLP compliance:

no

Remarks:

Pre-dates GLP inception

Type of study:

guinea pig maximisation test

Species:

guinea pig

Strain:

Hartley

Sex:

male

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Bantin and Kingman, Hull, Yorks
- Weight at study initiation: 300-400 g
- Housing: Grid floor cages
- Diet (e.g. ad libitum): Guinea pig diet (SCP from Labsure A.F. Limited, Poole, Dorset)

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12 hour photo-period

Route:

intradermal and epicutaneous

Vehicle:

water

Remarks:

(water for injections BP)

Concentration / amount:

0.5 % v/v in the first (intradermal injection) induction phase and as supplied in the second induction phase and the challenge application

Route:

epicutaneous, occlusive

Vehicle:

water

Remarks:

(water for injections BP)

Concentration / amount:

0.5 % v/v in the first (intradermal injection) induction phase and as supplied in the second induction phase and the challenge application

No. of animals per dose:

12, with 10 control animals

Details on study design:

RANGE FINDING TESTS:
Doses were selected based on a preliminary series of injections which demonstrated that the dose levels were well tolerated by the experimental animals. 4 animals were exposed to injections of 1.0, 0.5 and 0.1 % v/v in liquid paraffin.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: The first exposure was performed by intra-dermal injections, the second, topical exposure was applied seven days after the first induction for 48 hours
- Site: Please refer to the figure below for details. The exposure area was the shoulder region
- Frequency of applications: The second exposure was performed seven days after the first.
- Concentrations: 0.5 % v/v

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Two weeks after the final induction exposure
- Exposure period: 24 hours
- Site: Please refer to the figure below for details. The patches were applied to the flanks of the test animals
- Concentrations: Used as received
- Evaluation (hr after challenge): At 24 hours after patch removal, the test site was assessed for skin irritation. At this point any irritation caused by the tape would have subsided, and any sensitisation reactions would be at a peak. The sites were examined again 24 hours later. Three hours prior to the first reading, the test site was clipped free of hair and the skin gently cleansed of excess chemical with ether.

The reactions were assessed using the following scale
No reaction 0
Scattered mild erythema 1
Moderate diffuse erythema 2
Intense erythema and oedema 3

Challenge controls:

The substance was applied undiluted to 10 control animals who had not previously been subjected to induction without exposure to the test material.

Positive control substance(s):

no

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

0.5 %

No. with + reactions:

0

Total no. in group:

12

Clinical observations:

No effects noted

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.5 %. No with. + reactions: 0.0. Total no. in groups: 12.0. Clinical observations: No effects noted.

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

0.5 %

No. with + reactions:

0

Total no. in group:

12

Clinical observations:

No effects noted

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.5 %. No with. + reactions: 0.0. Total no. in groups: 12.0. Clinical observations: No effects noted.

Table 1: Results of preliminary test

Guinea Pig Number	Concentration of Test Material	Reaction Exhibited 7 Day Following Injection
1	1.0 % v/v in liquid paraffin B.P.	Raised necrotic reaction
	0.5 % v/v in liquid paraffin B.P.	Slight raised reaction
	0.1 % v/v in liquid paraffin B.P.	Slight raised reaction
2	1.0 % v/v in liquid paraffin B.P.	Raised necrotic reaction
	0.5 % v/v in liquid paraffin B.P.	Slight raised reaction
	0.1 % v/v in liquid paraffin B.P.	Slight raised reaction
3	1.0 % v/v in liquid paraffin B.P.	Raised necrotic reaction
	0.5 % v/v in liquid paraffin B.P.	Slight raised reaction
	0.1 % v/v in liquid paraffin B.P.	Slight raised reaction
3	1.0 % v/v in liquid paraffin B.P.	Raised necrotic reaction
	0.5 % v/v in liquid paraffin B.P.	Slight raised reaction
	0.1 % v/v in liquid paraffin B.P.	Slight raised reaction

 

Table 2: Effects of intradermal injections (induction phase A)

Guinea Pig Number	Reaction exhibited 7 days following injection
5	1.      Marked inflammatory reaction at Freund's Adjuvant sites.       2.      Slight inflammatory responses at test material sites.       3.      Marked inflammatory reaction at Freund's Adjuvant/test material sites.
6
7
8
9
10
11
12
13
14
15
16

 

Table 3: Effects observed following topical application (induction phase B) using 10 % sodium lauryl sulphate (in petrolatum)

Guinea Pig Number	Reaction exhibited on removal of occlusive units
5	Mild to moderate inflammatory response (grade 1-2)
6
7
8
9
10
11
12
13
14
15
16

 

Table 4: Results of challenge phase, control group

Guinea Pig Number	Concentration of test material	Reaction exhibited at:
		48 hours	72 hours
5	As supplied	0	0
	50 % in petrolatum	0	0
6	As supplied	0	0
	50 % in petrolatum	0	0
7	As supplied	0	0
	50 % in petrolatum	0	0
8	As supplied	0	0
	50 % in petrolatum	0	0
9	As supplied	0	0
	50 % in petrolatum	0	0
10	As supplied	0	0
	50 % in petrolatum	0	0
11	As supplied	0	0
	50 % in petrolatum	0	0
12	As supplied	0	0
	50 % in petrolatum	0	0
13	As supplied	0	0
	50 % in petrolatum	0	0
14	As supplied	0	0
	50 % in petrolatum	0	0
15	As supplied	0	0
	50 % in petrolatum	0	0
16	As supplied	0	0
	50 % in petrolatum	0	0

 

Table 5: Results of challenge application

Guinea Pig Number	Concentration of test material	Reaction exhibited at:
		48 hours	72 hours
5	As supplied	0	0
6	As supplied	0	0
7	As supplied	0	0
8	As supplied	0	0
9	As supplied	0	0
10	As supplied	0	0
11	As supplied	0	0
12	As supplied	0	0
13	As supplied	0	0
14	As supplied	0	0
15	As supplied	0	0
16	As supplied	0	0

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

Under the conditions of the study, the test substance was found to be not sensitising in Hartley guinea pigs.

Executive summary:

The sensitisation potential of the test substance was assessed in a guinea pig maximisation test. The method employed (Magnusson B and Kligman AM (1969) The Identification of Contact Allergens by Animal Assay – The Maximisation Test. J. Invest. Dermatol. Vol. 52, No. 3 p. 268-276) was an early method, which the modern guideline OECD 406 is based on. The results of the study are considered to be suitable for assessing the test substance. Under the conditions of the study, the test substance was found to be not sensitising in Hartley guinea pigs.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Migrated from Short description of key information:
Key study:- Anon. (1980) Skin sensitisation, guinea pig maximisation test: Not-sensitising (0.5 % v/v)

Justification for selection of skin sensitisation endpoint:
The key study for this endpoint, Anon (1980), assessed the skin sensitising potential of 3-methyl-5-phenylpentanol in a guinea pig maximisation test. The study was performed to a method on which the modern OECD guideline 406 was based on. Although compared to the guideline the study does contain some methodological deficiencies, it was reported in sufficient detail and performed in line with good scientific principles, achieving its objectives. The study was therefore assigned a reliability score of 2 in accordance with Klimisch (1997). Under the conditions of the test, no sensitisation was recorded.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

According to the EU Regulation EC 1272/2008 and Directive 67/548/EEC, the substance does not meet the criteria for classification for skin sensitisation.