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Toxicological information

Skin irritation / corrosion

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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:
other: non-GLP Guideline Study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 1,4-Butindiol fest
- Physical state: solid
- Analytical purity: >99%

Test animals

Species:
rabbit
Strain:
other: Russian, white Chbb-SPF (THOM)
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Fa. Dr. Karl Thomae GmbH, Biberach
- Age at study initiation: no data
- Weight at study initiation: 2.2 (female) and 2.6 kg (male)
- Diet (e.g. ad libitum): K4 Alleindiät für kaninchen, ad libitum
- Water (e.g. ad libitum): tap, ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20
- Humidity (%): 60
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 grams of the solid, unchanged (no vehicle)
Duration of treatment / exposure:
4 hours
Observation period:
14 days, with observations at 1, 24, 48 and 72 hours and 6, 8, 10, and 14 days.
Number of animals:
6; 3 males & 3 females
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: not reported
- Type of wrap if used: 6 x 6 cm polyethylene wrap secured with flexible bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, water
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize, et. al.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal 1
Time point:
other: 24 to 72 hours
Score:
2.7
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animals 2, 3, 4, and 6 (individually)
Time point:
other: 24 to 72 hours
Score:
3.3
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal 5
Time point:
other: 24 to 72 hours
Score:
3
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal 1
Time point:
other: 24 to 72 hours
Score:
3.7
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
animals 2 and 3
Time point:
other: 24 to 72 hours
Score:
4
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
animals 4 and 5
Time point:
other: 24 to 72 hours
Score:
3.3
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal 6
Time point:
other: 24 to 72 hours
Score:
3
Max. score:
4
Irritant / corrosive response data:
No necrosis in the first 3 minutes. All animals showed severe erythema and edema within 24 hours and signs of necrosis within 72 hours. Scab formation, tissue replacement, and scarring was also observed.

Any other information on results incl. tables

Reading

Animal

Erythema

Oedema

1 hour

1/2/3/4/5/6

0/1/1/1/1/1

4/4/4/4/3/4

24 hour

1/2/3/4/5/6

2/3/3/3/3/3

4/4/4/4/4/3

48 hour

1/2/3/4/5/6

2/3/3/3/3/3

4/4/4/3/3/3

72 hours

1/2/3/4/5/6

4/4/4/4/3/4

3/4/4/3/3/3

Average, each animal

1/2/3/4/5/6

2.7/3.3/3.3/3.3/3.0/3.3

3.7/4.0/4.0/3.3/3.3/3.0

Average, all animals

------

3.15

3.55

Applicant's summary and conclusion