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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:
1994/05/12 - 1996/04/11
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: modified methods of CTFA Safety Testing Guidelines, published by the Cosmetic, Toiletry and Fragrancy Association on September 27, 1985, and Preclinical Safety Evaluation of Materials used in Medical Devices HIMA Report 85-1.
Deviations:
yes
Remarks:
The water contained Trihalomethane (162 μg/l) that was above the EPA recommended level of 100 μg/l.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
guinea pig
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS

- Source: not stated

- Age at study initiation: ca. 3 months

- Weight at study initiation: 2.31-2.59 kg

- Housing: individual housing, in conventional design stainless steel cages

- Diet: Purina 5325 Certified High Fiber Rabbit Chow, ad libitum

- Water: ad libitum

- Acclimation period: 7 day quarantine


ENVIRONMENTAL CONDITIONS

- Temperature (°F): 61-70

- Humidity (%): 40-60

- Air changes (per hr): 10-15

- Photoperiod (hrs dark / hrs light): 12/12


Test system

Type of coverage:
other: occluded, semi-occluded or open
Preparation of test site:
other: intact and abraded
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL

- Amount(s) applied (volume or weight with unit): 0.5 ml

- Concentration (if solution): undiluted


Duration of treatment / exposure:
10 applications over 14 days
Observation period:
14 days
Number of animals:
3/group
Details on study design:
TEST SITE

- Area of exposure: the back

- Type of wrap if used: For occlusive application; a cotton gauze patch covered with a piece of SARAN plastic wrap, held in place by a cotton cloth bandage taped to their hair for 24 hours. Semi-occlusive wrap; a cotton gauze patch, held in place by a cotton cloth bandage taped to the hair for 24 hours. For unocculuded applicaiton, no wrap was used.


REMOVAL OF TEST SUBSTANCE

- Washing (if done): not reported


SCORING SYSTEM: The skin responses were cored on a 0-4 scale, 0 representing no reaction and 4 representing a severe reaction.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: Occluded application
Basis:
other: Repeated application
Time point:
other: Repeated 14 day exposure
Max. score:
2
Remarks on result:
other: Very slight to well defined erythema. See Table 1 for complete mean values.
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Occlusive group: very slight to well defined erythema and moist exfoliation was observed in all animals in this group by the fourth day of testing and continued throughout the study (abraded sites were healed by the fourth test day). A difference between intact and abraded sites showed a persistence of exfoliation at the abraded sites (exfoliation was present days 4 through 6 at intact sites and days 4 through 10 at abraded sites).

Semi-occlusive group: no test material - related irritation was observed in these animals during the study (abraded sites were healed by the fourth test day). No differences were observed between the intact and abraded sites.

Unoccluded group: No irritation was observed in animals during the course of the study (abraded sites were healed by the fourth day). No differences were seen between the intact and abraded sites.
Other effects:
There were no apparent test material-related effects on clinical signs, food consumption or body weight gains. The occluded wrapped animals gained less weight than the other groups. This equivocal result was possibly due to the occlusive wrappings.

Any other information on results incl. tables

Table 1: Mean Skin irritation scores at various intervals (30 minutes scoring)

Method

Skin Response

 

Score after application number*

1

2

3

4

5

6

7

8

9

10

Occlusive

ErythemaMax. score: 4

0/0

0/0

0/0

2/2

2/2

1.3/1.3

0/1

0.7/1.7

1/1.7

0/1

 

Edema     Max. score: 4

0/0

0/0

0/0

0/0

0/0

0/0

0/0

0/0

0/0

0/0

Semi-occlusive

ErythemaMax. score: 4

0/0

0/0

0/0

0/0

0/0

0/0

0/0

0/0

0/0

0/0

 

Edema     Max. score: 2

0/0

0/0

0/0

0/0

0/0

0/0

0/0

0/0

0/0

0/0

Unoccluded

ErythemaMax. score: 4

0/0

0/0

0/0

0/0

0/0

0/0

0/0

0/0

0/0

0/0

 

Edema     Max. score: 2

0/0

0/0

0/0

0/0

0/0

0/0

0/0

0/0

0/0

0/0

 *intact/abraded

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In a test that was conducted in accordance with a suitable test guideline and in compliance with GLP, L2 did not meet the criteria for classification as a skin irritant in the EU. The study involved repeated applications over 14 days and as such exceeds the requirements of the OECD 404 skin irritation study.