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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
Study period:
11 October 1993 to 22 November 1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline line compliant, GLP study conducted at reputable laboratory.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
The test material typically contains >94% of the trans (E) isomer and 4-5% of the cis (Z) isomer.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River UK Ltd
- Age at study initiation: 13-15 weeks old
- Weight at study initiation: 3.1 to 3.5 kg
- Housing: individually in plastic cages with perforated flooring
- Diet (e.g. ad libitum): SDDS Stanrab (P) Rabbit diet ad libitum
- Water (e.g. ad libitum): ad libitum access to tap water
- Acclimation period: not stated

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19°C
- Humidity (%): 30-70
- Air changes (per hr): 19
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 11 October 1993 To: 23 October 1993

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 mL to one intact site per rabbit
Duration of treatment / exposure:
Four hours
Observation period:
13 days after application of test material
Number of animals:
Three
Details on study design:
TEST SITE
- Area of exposure: 25 x 25 mm

- Type of wrap if used: gauze pad covered by elastoplast elastic adhesive tape to provide semi-occlusive dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm water and blotting dry
- Time after start of exposure: 4 hours

SCORING SYSTEM: Standard Draize assessment. Rabbit skin was assessed approximately 60 minutes after removal of the treatment dressing and then on Days 2, 3, 4 (24, 48 and 72 hour assessments) and daily from day 5 to 13.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24-72 hours
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 13 days
Remarks on result:
other: Generally moderate erythema persisted from Day 1 to day 6 in all three rabbits, ameliorating subsequently and overtly resolved by Day 9 or 13.
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24-72 hours
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 9-11 days
Irritant / corrosive response data:
All three rabbits developed well-defined erythema and slight oedema that persisted from the initial assessment to Day 6 (moderate oedema was recorded on a single occasion for one rabbit, Day 4, but the response was atypical). Slight or very slight reactions persisted with evidence of desquamation over the following week and all reactions had resolved by Day 9 (one rabbit) or Day 13 (two rabbits).
The overall response with means of 2.0 or greater for both erythema and oedema indicated potential for skin irritancy.

Any other information on results incl. tables

Irritation scores (individual animals)

 

1h

24h

48h

72h

Mean (24-72h)

4d

5d

6d

7d

8d

9d

10d

11d

12d

13d

Erythema

2,2,2

2,2,2

2,2,2

2,2,2

2.00 

2,2,2

2,2,2

2,2,2

1,2,2

1,2,2

0,2,2

1,1

1,1

1,1

0,0

Oedema

2,2,2

2,2,2

2,2,2

2,2,2

 2.00

2,2,2

2,2,2

2,2,2

1,1,1

1,1,1

0,1,1

1,1

0,0

0,0

0,0

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The results of this study indicate skin irritation but are not sufficient to trigger classification for skin irritation according to the CLP Regulation.
Executive summary:

In a standard three rabbit assessment of dermal irritation, following 4 hour exposure of intact skin under semi-occluded conditions, slight to well-defined oedema and erythema were observed in all three rabbits, reactions persisted for up to 12 days after application but reversibility was confirmed by Day 13. The results of this study do not trigger classification for skin irritation according to the CLP Regulation.