Registration Dossier

Administrative data

Endpoint:
skin irritation / corrosion, other
Remarks:
According to OECD 404
Type of information:
experimental study
Adequacy of study:
key study
Study period:
18 October 1982 to 25 October 1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted to GLP in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
other: Procedure similar to the proposed guidelines of the United States EPA, Paragraph 163.81-5 “Primary dermal irritation study”, Federal Register, Vol. 43 No. 163, August 22, 1978
Deviations:
yes
Remarks:
: the procedure was based upon the guideline but was not in every part identical.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
: the animals were exposed to the test material for 24 hours in an occlusive fashion; there was no evaluation 60 minutes after patch removal and the observation period lasted only 7 days.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid that tends to crystallise
Details on test material:
- Appearance: clear liquid, tends to crystallise

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2 - 3 kg
- Housing: Individually in metal cages.
- Diet (e.g. ad libitum): Rabbit food, ad libitum.
- Water (e.g. ad libitum): ad libitum.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 55 ± 15 %
- Air changes (per hr): Approximately 15 per hour.
- Photoperiod (hrs dark / hrs light): 12 hours light per day.

IN-LIFE DATES: From: 18 October 1982 To: 25 October 1982

Test system

Type of coverage:
occlusive
Preparation of test site:
other: shaved and abraded
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
- Volume: 0.5 mL of the test material
Duration of treatment / exposure:
24 hours
Observation period:
7 days
Number of animals:
6; 3 male and 3 female
Details on study design:
SITE PREPARATION:
-24 hours before exposure, the flanks of the test animals were shaved using an electric clipper. Immediately prior to treatment, the skin on one side was slightly scarified by means of a "Schroepfschnaepper".

TEST SITE
- Patch Size: Gauze patches 2.5 x 2.5 cm soaked with the test material were applied to intact and abraded skin sites. The patches were covered with an impermeable material and were fastened to the body of the rabbit with adhesive tape.

SCORING SYSTEM: The skin reactions were assessed upon patch removal and during the subsequent 7 day observation period in accordance with the Draize scale (1977).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Remarks:
of 6 animals
Time point:
other: mean of 24 and 72 hour evaluations
Score:
5.6
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: Both shaved and abraded skin
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: mean of 24, 48 and 72 hour evaluations
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: Shaved skin
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: mean of 24, 48 and 72 hour evaluations
Score:
2.9
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: Abraded skin
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: mean of 24, 48 and 72 hour evaluations
Score:
2.7
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: Shaved skin
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: mean of 24, 48 and 72 hour evaluations
Score:
2.6
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: Abraded skin
Irritant / corrosive response data:
Necrosis and extended erythema was observed in all 6 animals.

Any other information on results incl. tables

Table 1 PII at 24 and 72 hours.

PII = total ÷ 4

Time After Exposure (hours) Mean Erythema Scores Mean Oedema Scores
Intact Skin Abraded Skin Intact Skin Abraded Skin
24 3.0 3.0 2.8 2.7
72 3.0 2.8 2.7 2.5
     
Subtotal 6.0 5.8 5.5 5.2
Total 22.5      
PII 5.6      

Table 2 Individual Scores

Shaved

Time After Exposure (hours) Male Female Average
1 2 3 1 2 3  
Erythema 24 hours 3 3 3 3 3 3 3.0
  48 hours 3 3 3 3 3 3 3.0
  72 hours 3 3 3 3 3 3 3.0
  4 days 3 3 3 3 3 3 3.0
  7 days 3 2 3 2 2 3 2.5
Oedema 24 hours 3 3 3 2 3 3 2.8
  48 hours 3 2 2 2 3 3 2.5
  72 hours 4 2 2 2 3 3 2.7
  4 days 4 2 2 2 3 3 2.7
  7 days 4 2 2 2 2 2 2.3
    Abraded
Erythema 24 hours 3 3 3 3 3 3 3.0
  48 hours 2 3 3 3 3 3 2.8
  72 hours 2 3 3 3 3 3 2.8
  4 days 2 3 3 3 3 3 2.8
  7 days 2 2 3 2 2 2 2.2
Oedema 24 hours 2 3 3 2 3 3 2.7
  48 hours 2 2 3 2 3 3 2.5
  72 hours 2 2 4 2 3 2 2.5
  4 days 2 2 4 2 3 2 2.5
  7 days 2 2 3 1 2 2 2.0

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the study, the test material was shown to cause marked irritation to the skin of rabbits and as such is classified as a category 2 skin irritant in accordance with EU criteria.
Executive summary:

The skin irritancy potential of the test material was assessed in a GLP compliant in vivo study that was based upon the procedure outlined in the guidelines of the United States EPA, Paragraph 163.81-5 “Primary dermal irritation study”, Federal Register, Vol. 43 No. 163, August 22, 1978.

Six New Zealand White rabbits were exposed to the test material in an occlusive fashion for 24 hours on both intact and abraded skin. The skin reactions were evaluated in accordance with the Draize scale at 24, 48 and 72 hours followed by observations after 4 and 7 days.

Under the conditions of this study, the test material produced marked irritation to the skin and as such requires classification as “Category 2, H315: Causes skin irritation” with signal word “Warning” in accordance with EU criteria.