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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:
From Sep. 14, 1981 to Sep. 21, 1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPP 81-5 (Acute Dermal Irritation)
Deviations:
yes
Remarks:
-protocol with occlusive application for 24h, which is more stringent than the OECD guideline 404, and observation period should be up to 14 days to determine reversibility effects
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Bred and raised rabbits on the premises (Ciba-Geigy Ltd. - Exp. Toxicology Sisseln GU 2.1)
- Age at study initiation: Adults
- Weight at study initiation: 2 to 3 kg
- Housing: Housed individually in metal cages
- Diet (e.g. ad libitum): ad libitum, standard rabbit food (NAFAG No. 814, Gossau SG)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum of 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
other: polyethylene glycol (PAG 400) + saline (70:30 parts)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): 50%

VEHICLE
- Amount(s) applied (volume or weight with unit): Not reported
- Concentration (if solution): 70:30 parts of polyethylene glycol (PAG 400) + saline
Duration of treatment / exposure:
24 hours
Observation period:
7 days
Number of animals:
3 males and 3 females
Details on study design:
TEST SITE
- Area of exposure: Before treatment, the entire back and flank of the rabbits were shaved and immediately before treatment the shaven skin on one side was slightly scarified. The test material was applied to the prepared abraded and intact skin.
- % coverage: 2.5 cm x 2.5 cm
- Type of wrap if used: The patches were covered with an impermeable material and were fastened to the body of the rabbit with adhesive tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not reported
- Time after start of exposure: 24 hours
The dressings were removed after a 24 hour application.

SCORING SYSTEM: The skin reaction was appraised upon removal and during an observation period of 7 days on the basis of the following evaluation scheme.

Score for skin irritation in rabbits
Erythema and eschar formation
No erythema - 0
Very slight erythema (barely perceptible) - 1
Well defined erythema - 2
Moderate to severe erythema - 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) - 4
Total possible erythema score - 4

Edema formation
No edema - 0
Very slight edema (barely perceptible) - 1
Slight edema (edges of area well defined by definite raising) - 2
Moderate edema (raised approximately 1 mm) - 3
Severe edema (raised more than 1 mm and extending beyond area of exposure) - 4
Total possible edema score - 4

Assessment of irritation:
0
0.1-1.0 = minimal
1.1-2.0 = slight
2.1-4.0 = moderate
4.1-6.0 = marked
6.1-8.0 = extreme

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Remarks:
intact skin
Basis:
mean
Time point:
24 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
overall irritation score
Remarks:
intact skin
Basis:
mean
Time point:
48 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
overall irritation score
Remarks:
intact skin
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Irritation parameter:
overall irritation score
Remarks:
intact skin
Basis:
mean
Time point:
other: 4 days
Score:
0
Max. score:
4
Reversibility:
not specified
Irritation parameter:
overall irritation score
Remarks:
intact skin
Basis:
mean
Time point:
7 d
Score:
0
Max. score:
4
Reversibility:
not specified
Irritation parameter:
overall irritation score
Remarks:
abraded skin
Basis:
mean
Time point:
24 h
Score:
1.7
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
overall irritation score
Remarks:
abraded skin
Basis:
mean
Time point:
48 h
Score:
1.2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
overall irritation score
Remarks:
abraded skin
Basis:
mean
Time point:
72 h
Score:
0.3
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
overall irritation score
Remarks:
abraded skin
Basis:
mean
Time point:
other: 4 days
Score:
0.3
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
overall irritation score
Remarks:
abraded skin
Basis:
mean
Time point:
7 d
Score:
0.2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
24 h
Score:
0.8
Max. score:
8
Reversibility:
not specified
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
72 h
Score:
0.8
Max. score:
8
Reversibility:
not specified
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
not specified
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
not specified
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
0.3
Max. score:
4
Reversibility:
not specified
Irritation parameter:
edema score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
not specified
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Irritant / corrosive response data:
The test item was found to cause a minimal irritation when applied to intact and abraded rabbit skin.
The primary irritation index was 1.3//0.3 for erythema/edema at 24h and 0.0/0. for erythema/oedema at 72h for intact skin. No further findings on intact skin appeared until the last day of the observation period (day 7). Findings on abraded skin were still observed in one animal on day 7

Any other information on results incl. tables

Table 1. Primary Irritation Score

Time after exposure (hours)

Mean reaction score

Erythema

Edema

Intact skin

Abraded skin

Intact skin

Abraded skin

24

1.0

1.3

0.3

0.3

72

0

0.3

0

0

Total

1.0

1.6

0.3

0.3

The scores read after 24 and 72 hours for erythema and edema for the intact as well as for the abraded skin were summed up and divided by 4.

Total = 1.0 + 1.6 + 0.3 + 0.3 = 3.2

Primary irritation index = 3.2 / 4 = 0.8

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item was found to be not irritant to the skin under the test conditions.