Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
October 13, 1983 - October 20, 1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP study following OECD guideline 404 performed under GLP-like QAU surveillance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
(1981)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: viscous liquid
- Analytical purity: commercial grade
- Storage condition of test material: room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation: 12 - 14 weeks
- Weight at study initiation: 211 - 2440 g
- Housing: Animals were housed individually in metal cages.
- Diet: Rabbit food, NAFAG, No. 814 Tox, NAFAG AG,Gossau, SG (Switzerland), ad libitum
- Water: ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
Duration of treatment / exposure:
4 h
Observation period:
Skin reaction was evaluated after 1, 24, 48, 72 hours.
Number of animals:
3 females
Details on study design:
TEST SITE
- Area of exposure: 6 sq. cm
- Type of wrap if used: A gauze patch bearing 0.5 ml of the test substance was applied to the skin and loosely held in place by adhesive but non irritating tape

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 4h

SCORING SYSTEM:
Erythema and Eschar Formation
No erythema = 0
Very slight erythema = 1
Well defined erythema = 2
Moderate to severe erythema = 3
Severe erythema (beet redness) to slight eschar formation = 4
Corrosion = +

Oedema Formation
No oedema = 0
Very slight oedema = 1
Slight oedema (edges of area well defined by definite raising) = 2
Moderate oedema (appr. 1 mm) = 3
Severe oedema (raised more than 1 mm, extended beyond appl. site) = 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 1, 24, 48, 72 h
Score:
5.92
Max. score:
8
Remarks on result:
other: considered as severly irritant
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
3.6
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
3
Max. score:
4
Irritant / corrosive response data:
The test article caused severe irritant and corrosive reactions when applied to the rabbit skin; there was no tendency of recovery towards the end of the observation period. Due to extreme irritation in the skin the animals were killed after the 72 h scoring out of animal protection reasons.
Other effects:
The animals showed a normal body weight development.

Any other information on results incl. tables

Table 1 - Evaluation of the dermal reactions

Animal No. /Sex 1h 24h 48h 72h
Erythema and eschar formation
78/F 2 3 4+ 4+
79/F 2 3 4+ 4+
80/F 2 2 4+ 4+
Total

6 + 8 +  12 +  12 =  38  

         
Oedema formation
78/F 2 3 3 3
79/F 2 3 3 3
80/F 2 3 3 3
Total

6 + 9 +  9 +  9 =  33  

+ = corrosion

INDEX of skin irritation : 38 + 33 = 71 : 12 = 5.92 (= severly irritant)

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information
Conclusions:
Under the conditions of the present experiment the test substance was found to be severely irritant and corrosive when applied to the rabbit skin.
Executive summary:

In a skin irritation study following OECD guideline 404 (1981) and performed under GLP-like QAU surveillance, 0.5 ml of the test article was applied to the rabbit skin under semiocclusive conditions for 4 hours. After removal of the dressings the skin reaction was assessed after 1, 24, 48 and 72 hours according to the Draize scoring scheme presented in the OECD guideline. The test substance was found to be severely irritant and corrosive when applied to the rabbit skin; there was no tendency of recovery towards the end of the observation period. Due to extreme irritation in the skin the animals were killed after the 72 h scoring out of animal protection reasons. Based on these results, the test substance was considered to be corrosive to the skin and requires classification.