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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:
01 December 1997 - 09 January 1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): CN386 (Amine synergist)- Physical state: Clear colourless liquid- Lot/batch No.: CK664- Storage condition of test material: Room temperature and humidity

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS- Source: Ace Animals, Boyertown, PA, USA- Weight at study initiation: 2.2 - 2.6 kg- Housing: Individually in suspended wire cages- Diet (e.g. ad libitum): Purina Rabbit Chow (Diet no. 5321)- Acclimation period: At least 5 daysENVIRONMENTAL CONDITIONS- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL- Amount(s) applied (volume or weight with unit): 0.5 ml/rabbit
Duration of treatment / exposure:
4 hours
Observation period:
14 days
Number of animals:
3
Details on study design:
TEST SITE- Area of exposure: 2.5 x 2.5 cm- Type of wrap if used: PlasticREMOVAL OF TEST SUBSTANCE- Washing (if done): Gentle washing with distilled water at the end of the exposure period, before scoring for dermal reactions- Time after start of exposure: 4 hoursSCORING SYSTEM: Numerical Draize technique

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: Erythema and eschar formation, mean score
Basis:
animal: 1, 2 and 3
Time point:
other: 24 hours
Score:
2.33
Max. score:
4
Irritation parameter:
other: Erythema and eschar formation, mean score
Basis:
animal: 1, 2 and 3
Time point:
other: 72 hours
Score:
2
Max. score:
4
Irritation parameter:
edema score
Remarks:
mean value
Basis:
animal: 1, 2 and 3
Time point:
other: 24 hours
Score:
1.67
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: 1, 2 and 3
Time point:
other: 72 hours
Score:
1.33
Max. score:
4
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Score:
3.67
Irritant / corrosive response data:
Erythema scores, very slight to well defined at 1 hour following patch removal, ranged from absent to severe through Day 1 and cleared by Day 14.One animal had poor hair regrowth on Day 7, which cleared by Day 14. Edema scores generally ranged from absent to slight through Day 7 and cleared by Day 14, with the exception of a score 3 (moderate) in one animal at 24 hours.

Any other information on results incl. tables

Table 1: Bodyweights (BW)
Rabbit N° 1 2 3
Pretest BW (kg) 2.2 2.6 2.2
Terminal BW 2.5 2.5 2.6

Table 2: Erythema and eschar formation
Rabbit N° 1 2 3 Mean
Time after patch removal       Score
1 h 1 1 2  
24 h 1 2 4 2.33
48 h 2 2 4  
72 h 0 2 4 2.00
7 d 0 2 4  
14 d 0 0 0  
Table 3: Edema
Rabbit N° 1 2 3 Mean
Time after patch removal       Score
1 h 0 0 2  
24 h 0 3 2 1.67
48 h 0 2 2  
72 h 0 2 2 1.33
7 d 0 1 2  
14 d 0 0 0  
Sum of mean scores       7.33
PDII       3.67
Table 4: Systemic observations
Rabbit N° 1 2 3
Time after patch removal      
1 h A A A
24 h A A A
48 h A A A
72 h A A A
7 d A A A
14 d A D A
A: normal; D: diarrhea

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the test conditions, the test substance was considered to be irritating but not corrosive to skin.
Executive summary:

A study was performed to assess the skin irritation potential of the test substance to the skin of New Zealand White rabbits according to OECD Guideline 404.

0.5 mL of test substance was applied to the clipped skin area on the back of each animal under a 25 x 25 mm gauze pad. The pad was allowed to remain in contact with the skin for 4 h. Animals were scored for irritation reactions after 1, 24, 48 and 72 hours then 7 and 14 days.

The general health of the animals was monitored at each observation point (24, 48, 72 h, and 7 and 14 days). Bodyweights were recorded pre-test and at termination. Scoring was done according to the Draize methodology.

Erythema scores, very slight to well defined at 1 hour following patch removal, ranged from absent to severe through Day 1 and cleared by Day 14. One animal had poor hair regrowth on Day 7, which cleared by Day 14. Edema scores generally ranged from absent to slight through Day 7 and cleared by Day 14, with the exception of a score 3 (moderate) in one animal at 24 hours. The primary dermal skin irritation index was equivalent to 3.67.

Under the test conditions, the test substance was considered to be irritating but not corrosive to skin.