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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:
29 January - 11 February 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 guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
(adopted 17 July 1992)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Date of Inspection: 22 January 1996

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): MR6B (PEMP)
- Substance type: Organic
- Physical state: Colourless slightly viscous liquid
- Storage condition of test material: Approximately 4°C in the dark over silica gel
- No information on purity
Specific details on test material used for the study:
The test was performed with PEMP product, the registered substance.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, U.K.
- Age at study initiation: 12 - 16 weeks
- Weight at study initiation: 2.63 - 2.92 kg
- Housing: Individually, in suspended metal cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 21
- Humidity (%): 48 - 65
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 29 January 1998 To: 11 February 1998

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5mL
Duration of treatment / exposure:
3 minutes, 1 hour and 4 hours
Observation period:
72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5cm * 2.5cm
- Type of wrap if used: Test substance was applied under cotton gauze patch, which was secured by surgical adhesive tape (BLENDERM) and the trunk of each animal was wrapped in an elastic corset (TUBIGRIP)

REMOVAL OF TEST SUBSTANCE
- Washing: Test substance was wiped from skin with cotton wool soaked in 74% Industrial Methylated Spirits
- Time after start of exposure: 3 minutes, 1 hour and 4 hours (one animal), 4 hours (two additional animals)

SCORING SYSTEM: Following the scale developed by Draize (1977):"Dermal and Eye Toxicity Tests", in: Principles and Procedures for Evaluating teh Toxicity of Household Substances, National Academy of Sciences, Washington DC p. 31.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of 3 rabbits
Time point:
other: 24 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of 3 rabbits
Time point:
other: 48 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of 3 rabbits
Time point:
other: 72 hours
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 3 rabbits
Time point:
other: 24 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
Exposure for 3 minutes did not induce skin effects.
Exposure for 1 hour gave an erythema score of 1 one hour after removal of the test substance and at the 24- and 48-hour observations. The erythema had fully resolved after 72 hours.
Exposure for 4 hours resulted in very slight erythema at one of the treated skin site one hour after patch removal, at all treated skin sites at the 24- and 48-hour observations and at two treated skins at the 72-hour observation. One treated skin appeared normal at the 72-hour observation and two treated skin sites appeared normal at the 7-day observation. No edema was seen.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on a skin irritation test performed according to OECD/ EC guidelines and GLP principles with PEMP, PEMP is not classified for skin irritation.
Executive summary:

A skin irritation test was performed with PEMP according to OECD/ EC guidelines and GLP principles. One rabbit was exposed semi-occlusively for 3 minutes, 1hour and 4 hours. Subsequently two additional rabbits were exposed semi-occlusively for 4 hours.

Exposure for 3 minutes did not induce adverse skin effects. Exposure for 1 hour gave an erythema score of 1 one hour after removal of the test substance and at the 24- and 48-hour observations. The erythema had fully resolved after 72 hours. Exposure for 4 hours resulted in very slight erythema at one of the treated skin site one hour after patch removal, at all treated skin sites at the 24- and 48-hour observations and at two treated skins at the 72-hour observation. One treated skin appeared normal at the 72-hour observation and two treated skin sites appeared normal after 7 days.

Based on these data, PEMP was found to be not corrosive and not irritating to the skin, therefore the substance is not classified according to Regulation (EC) 1272/2008.