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Toxicological information

Skin sensitisation

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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:
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

Reference
Name:
Unnamed
Type:
Constituent
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)

Inductionopen allclose all
Route:
intradermal
Vehicle:
physiological saline
Concentration / amount:
25, 15, 10, 5 %
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
physiological saline
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 group
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