But-2-yne-1,4-diol

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

June 12, 1990 through July 13, 1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Version / remarks:

Guinea Pig Maximisation Test

Deviations:

no

GLP compliance:

yes

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

The study was performed in 1990.

Test material

Test material information

Constituent 1

Reference substance name:

But-2-yne-1,4-diol

EC Number:

203-788-6

EC Name:

But-2-yne-1,4-diol

Cas Number:

110-65-6

Molecular formula:

C4H6O2

IUPAC Name:

but-2-yne-1,4-diol

Details on test material:

- Name of test material (as cited in study report): Butin-2-diol-1,4
- Analytical purity:99.2 %
- Lot/batch No.: 370294
- Storage condition of test material: room temperature

In vivo test system

Test animals

Species:

guinea pig

Strain:

other: GOHI (Himalayan spotted guinea pigs)

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: BRL, Biological Research Laboratories, Füllinsdorf
- Age at study initiation: 8 weeks
- Weight at study initiation: 281 - 379 g
- Housing: Makrolon type-3 cages
- Diet: ad libitum
- Water :ad libitum
- Acclimation period: 1 week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 40 - 70%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

intradermal

Vehicle:

physiological saline

Induction 2

Concentration / amount:

25, 15, 10, 5 %

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

physiological saline

Challenge 2

Concentration / amount:

25, 15, 10, 5 %

No. of animals per dose:

10 animals for control group
20 animals for test group

Results and discussion

In vivo (non-LLNA)

Results

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

25 % test article dilution

No. with + reactions:

1

Total no. in group:

18

Clinical observations:

positive erythema reaction

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25 % test article dilution. No with. + reactions: 1.0. Total no. in groups: 18.0. Clinical observations: positive erythema reaction.

Any other information on results incl. tables

SENSITIZING EFFECTS

CONTROL GROUP:

No positive reactions were evident.

TEST GROUP:

Only 1 out of 18 test animals showed incidental positive erythema reactions at the 24-hour reading when treated with a 25% test article dilution. No further positive findings were observed, neither when treated with the vehicle alone nor when treated with the test article diluted to 25 % in physiological saline.

SYMPTOMS, LOCAL

TEST GROUP:

Application area around the injection sites 1 and 3 was found to show erythema, and edema from day 2 to 8; necroses from day 10 to18; encrustation from day 15 to19 and exfoliation from day16 to 25 (on day 9 of test, no observation could be performed because the animals were treated semi-occlusively).

Mortality: animal no. 281 (test group) died spontaneously and female no. 289 (test group) was killed in extremis on test day 3.

- animal no. 281; Lung: discoloration, dark red

- animal no. 289; Lung: discoloration, reddisch

Body weights: The body weight gain of the animals was not affected adversely during the study.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information

Conclusions:

Classification: not sensitizing