Pentane-1,2-diol

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:

other: Guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Version / remarks:

; original guideline 406, adopted in 1981

GLP compliance:

no

Type of study:

Maurer optimisation test

Test material

Test material information

Constituent 1

Reference substance name:

Pentane-1,2-diol

EC Number:

226-285-3

EC Name:

Pentane-1,2-diol

Cas Number:

5343-92-0

Molecular formula:

C5H12O2

IUPAC Name:

pentane-1,2-diol

In vivo test system

Test animals

Species:

guinea pig

Strain:

other: Pirbright white

Sex:

male/female

Details on test animals and environmental conditions:

TEST ANIMALS
- Age at study initiation: 10 weeks
- Weight at study initiation: 221 g - 451 g
- Housing: individually in Macrolon cages type 3
- Diet:. ad libitum
- Water: ad libitum
- Acclimation period: 12 days

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

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

intradermal

Vehicle:

physiological saline

Induction 2

Concentration / amount:

Induction intradermal:
0.1 ml of a 0.1 % solution of test item in physiological saline;
during the second and third week of the induction period the test material was incorporated in a mixture of the normal vehicle with complete Bacto Adjuvant (vehicle : adjuvant = 1 : 1)

Challenge intradermal:
0.1 ml of a 0.1 % solution of test item in physiological saline

Challenge epicutaneous:
10 % of test item in vaseline

Challenge

Challenge 1

Route:

intradermal and epicutaneous

Vehicle:

physiological saline

Challenge 2

Concentration / amount:

Induction intradermal:
0.1 ml of a 0.1 % solution of test item in physiological saline;
during the second and third week of the induction period the test material was incorporated in a mixture of the normal vehicle with complete Bacto Adjuvant (vehicle : adjuvant = 1 : 1)

Challenge intradermal:
0.1 ml of a 0.1 % solution of test item in physiological saline

Challenge epicutaneous:
10 % of test item in vaseline

No. of animals per dose:

10 male and 10 female animals

Details on study design:

During the induction period the animals received one injection every second day (except weekends) to a total of 10 intracutaneous injections of a freshly prepared 0.1% solution of test item in physiological saline. One control group was treated with the vehicle alone ("negative control" ) . On the first day, injections of 0.1 ml were administered into the shaved skin of the right flank and the back, while on the following days a single intracutaneous injection was given into the back. During the second and third week of the induction period the test material was incorporated in a mixture of the normal vehicle with complete Bacto Adjuvant (vehicle : adjuvant = 1 : 1).
Fourteen days after the last sensitizing injection, a challenge injection of 0.1 ml of a freshly prepared 0.1 % solution of test item in physiological saline was administered into the skin of the left flank. Twenty-four hours after each injection during the first week of the induction period and 24 hours after the challenge injection the reactions were recorded.
The two largest perpendicular diameters (in mm) and the increase in the skin-fold thickness (in mm) were measured and by multiplication of these values a "reaction volume" was obtained (in µl) for each reading from each animal. The mean volume plus one standard deviation of the induction reactions observed in the individual animal in the first week was taken as representing the skin irritation "threshold" for each animal. Any challenge reaction greater than this threshold value in the induction period was graded as an allergic reaction and the animal termed "positive". The number of "positive" animals in the test group was compared with the number of animals in the control croup (treated with the vehicle alone) that showed a non-specific reaction of at least the same magnitude ("negative control") .
Ten days after the intracutaneous challenge injection a subirritant dose of the test compound (10% test item in vaseline) was applied epicutaneously under occlusive dressings which were left in place for 24 hours. The reactions were evaluated 24 hours after removing of the bandages according the Draize scoring scale.

Positive control substance(s):

no

Results and discussion

In vivo (non-LLNA)

Results

Results 1

Reading:

other: Reading after intradermal challenge

Hours after challenge:

24

Group:

test chemical

Dose level:

0.1 ml of 0.1 % solution of test item in physiological saline

No. with + reactions:

0

Total no. in group:

20

Remarks on result:

other: Reading: other: Reading after intradermal challenge. . Hours after challenge: 24.0. Group: test group. Dose level: 0.1 ml of 0.1 % solution of test item in physiological saline. No with. + reactions: 0.0. Total no. in groups: 20.0.

Results 2

Reading:

other: reading after epicutaneous challenge

Hours after challenge:

24

Group:

test chemical

Dose level:

10 % solution of test item in vaseline

No. with + reactions:

0

Total no. in group:

20

Remarks on result:

other: Reading: other: reading after epicutaneous challenge. . Hours after challenge: 24.0. Group: test group. Dose level: 10 % solution of test item in vaseline. No with. + reactions: 0.0. Total no. in groups: 20.0.

Any other information on results incl. tables

Intradermal injections of the vehicle alone failed to induce sensitization.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information

Conclusions:

Under the experimental conditions employed the test item was found to be devoid of skin sensitizing potency in albino guinea pigs.