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Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
Acute toxicity of 1,4-butanediol in laboratory animals.
Author:
Jedrychowski et al.
Year:
1990
Bibliographic source:
Polish Journal of Occupational Medicine 3, (4), 415 - 420

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Draize, et. al., J Pharm Exp Ther 82, 377-390, 1994
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Butane-1,4-diol
EC Number:
203-786-5
EC Name:
Butane-1,4-diol
Cas Number:
110-63-4
Molecular formula:
C4H10O2
IUPAC Name:
butane-1,4-diol
Details on test material:
above 98%

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
White Vienna rabbits, body weight 3 .4 - 3 .8 kg, housed individually, were used to assess dermal irritation. Food (LSK, Plant, Motycz, Poland) and water were provided ad libitum.

TEST ANIMALS
- Source: Nofer Institute of Occupational Medicine husbandry
- Age at study initiation: no data
- Weight at study initiation: 3.4-3.8 kg
- Housing: Housed individually in stainless steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7-14 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-19
- Humidity (%): 55-65
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: To:

Test system

Type of coverage:
occlusive
Preparation of test site:
other: Shaved and abraded
Remarks:
intact (right side) and abraded (left side) skin
Vehicle:
unchanged (no vehicle)
Controls:
yes
yes, concurrent no treatment
no
other: Adjacent areas of untreated and water-treated skin of each animal served as a control for the test.
Amount / concentration applied:
0.3 ml
Duration of treatment / exposure:
24 hours
Observation period:
up to 72 hours after patch removal.
Number of animals:
4
Details on study design:
Fur from the side-areas of the trunk of all the rabbits was removed by cIipping and shaving to facilitate test material application. The gauze patches (2 x 2 cm) with 0.3 ml undiluted BAD (1,4-butanediol) were applied to the intact (right side) and abraded (left side) skin of animals. Adjacent areas of untreated and water-treated skin of each animal served as a control for the test. The patches were covered with plastic foil and protected by means of a suitable occIusive dressing for the 24 hrs exposure period. Observations for dermal irritation were made 1, 24, 48 and 72 hrs after patch removal. Dermal evaluation utilized the scoring system of Draize et al. Dermal irritancy ratings were determined using the cIassification system as folIows: slightly irritating < 2, moderately irritating 2 - 5, severely irritating > 5. The rabbits were used to assess short-term dermal irritation. The same internal areas of the right ears of rabbits were painted with either 100% or 50% BAD (1,4-butanediol) in water solution for 10 consecutive days incIuding weekend. The left ear of each rabbit painted with water served as a control for the test. Observations for dermal irritation were made the day after painting.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72 h
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Remarks on result:
no indication of irritation

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No dermal reaction was noted in rabbits with intact or abraded skin after a single 24 hour exposure. There was no skin reaction following short-term (10 consecutive days) dermal exposure to 50% BAD (1,4-butnanediol) in water. Only after 10 days a minimal reddening of the ear skin was observed in 2/4 rabbits treated with undiluted BAD (1,4-butanediol).