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Administrative data

Description of key information

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:
1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to an appropriate OECD test method and in compliance with GLP.
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Study was conducted in 1995
Specific details on test material used for the study:
- Name of test material (as cited in study report): 3-methyl-1,5-pentanediol MPD
- Physical state: liquid
- Analytical purity: >99 %
- Lot/batch No.: 52724
- Test substance recieved on (date): 30 September 1994
- Expiry date: end of 1996
- Storage condition of test material: room temperature in the dark
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: d. Hall, Newchurch, Staffordshire, England
- Age at study initiation: approx. 4 to 5 weeks
- Weight at study initiation: 305 - 358 g
- Housing: 5/suspended wire mesh cage
- Diet: vitamin C enriched guinea-pig diet FD1 ad libitum
- Water: drinking water ad libitum
- Acclimation period: 5 days prior to allocation to the main study

ENVIRONMENTAL CONDITIONS
- Temperature (°C): approx. 21 °C
- Humidity (%): 30-70
- Air changes (per hr): approx. 15 per hr
- Photoperiod (hrs dark / hrs light): 12 h/12 h
Route:
intradermal and epicutaneous
Vehicle:
water
Concentration / amount:
INDUCTION
intradermal: 5% (v/v)
dermal: neat
CHALLENGE
dermal: neat and 50% (v/v)
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
INDUCTION
intradermal: 5% (v/v)
dermal: neat
CHALLENGE
dermal: neat and 50% (v/v)
No. of animals per dose:
Test animals: 10
positive control animals: 5
Details on study design:
1st application: Induction 5 % (v/v) intradermal injection
2 st application: Induction neat epicutaneous
3 st application: Challenge neat and 50 % (v/v) epicutaneous
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
test group
Dose level:
100% and 50 % (v/v)
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No adverse skin reactions reported
Key result
Reading:
rechallenge
Hours after challenge:
48
Group:
test group
Dose level:
100% and 50%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No adverse skin reactions reported
Key result
Reading:
rechallenge
Hours after challenge:
72
Group:
test group
Dose level:
100% and 50%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No adverse skin reactions reported
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
negative control
Dose level:
100% and 50 % (v/v)
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
No adverse skin reactions reported
Key result
Reading:
rechallenge
Hours after challenge:
48
Group:
negative control
Dose level:
100% and 50%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
No adverse skin reactions reported
Key result
Reading:
rechallenge
Hours after challenge:
72
Group:
negative control
Dose level:
100% and 50%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
No adverse skin reactions reported

No adverse skin reactions were noted at the test material or vehicle control sites of the test or control animals at 24, 48 and 72 h observations.

Interpretation of results:
GHS criteria not met
Conclusions:
The guinea-pig maximization test found that 3-methyl-1,5-pentanediol (neat and 50% in water) did not elicit a delayed contact hypersensitivity response in guinea pigs. Appropriate concurrent negative controls were included and the expected responses observed.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

One Kligman-Magnusson Maximisation test with guinea pigs (Sahra A., Allan (1995)) is available, performed under GLP and in accordance with an appropriate EU test method. The guinea pigs in the sensitisation maximization test undergo an intradermal induction stage, followed by a topical induction stage, and a subsequent challenge period. During the intradermal induction stage, three pairs of intradermal injections were made within a clipped area: 1. Freundsche's complete adjuvant (FCA) diluted with water; 2. the test article 5% (v/v) in water as vehicle 3 and the test article 5% (v/v) in water with FCA and positive control. One week later 0.4 ml of the neat test substance was applied topically for 48 hours. Fourteen days after topical induction, the animals were challenged with neat test article and test article in 50 % (v/v) in distilled water, vehicle control or control under occluded patches for 24 hours. The challenge sites were evaluated 24, 48 and 72 hours after removal of the patches.


No irritation was observed after the challenge with neat test article and with test article 50 %(v/v) in water,except for transient slight erythema and oedema on the animals at the intradermal inductions with 5% (v/v) test article in water on the animals. Based on these results, 3 -methylpentane-1,5 -diol is considered not to have a skin sensitising potential.



Migrated from Short description of key information:
Based on the result of the GLP-compliant GPMT test (Kligman-Magnusson Maximisation test), 3-methylpentane-1,5-diol is not sensitising to skin.

Justification for selection of skin sensitisation endpoint:
One study is available. In this test no skin effects were observed.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

Justification for selection of respiratory sensitisation endpoint:
No data on respiratory sensitization are available. However, in accordance with Section 1 of REACH Annex XI, the study is scientifically unjustified, as respiratory tract sensitization is not expected based on the fact that 3-methylpentane-1,5-diol is not skin sensitizer and no human data are available indicating a concern for respiratory sensitization.

Justification for classification or non-classification

Based on the absence of skin sensitizing effect in a Kligman-Magnusson-Maximisation study with guinea pigs and the lack of data indicating respiratory sensitization by 3 -methylpentane-1,5 -diol, the substance is considered to be not sensitising according to Directive 67/548/EEC and EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.