Registration Dossier

Administrative data

Description of key information

In two skin irritation tests with PEMP, both performed according to OECD/ EC guidelines and GLP principles, no dermal effects were seen that would lead to classification for skin irritation. Furthermore an acute eye irritation test is available, performed with 3 rabbits according to OECD/EC guideline. As no adverse effects were seen in the treated eyes at 24, 48 and 72 hours, PEMP was found to be not irritating to the eye.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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
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
Specific details on test material used for the study:
The test was performed with PEMP product, the registered substance.
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
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.
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.
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
02JUL1992 - 09JUL1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
(1987), referenced as Method B5 in Commission Directive 84/449/EEC (which constitutes Annex V of Council Directive 67/548/EEC)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
date of inspection: 17MAR1992
Specific details on test material used for the study:
The test was performed with PEMP product, the registered substance.
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, United Kingdom
- Age at study initiation: 12 - 16 weeks
- Weight at study initiation: 2.90 - 3.48 kg
- Housing: individually, in suspended metal cages
- Diet: ad libitum (Spillers Rabbit Diet, Dalgety Agriculture Ltd., Almondsbury, Bristol, United Kingdom)
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-22
- Humidity (%): 58-66
- Air changes (per hr): appr. 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From 02JUL1992 to 09JUL1992
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye was used as control
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1mL
Duration of treatment / exposure:
Single instillation
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: No

SCORING SYSTEM: According to Draize, JH (1959), Association of Food and Drug Officials of the United States, Austin, Texas: "The Appraisal of the Safety of Chemicals in Food, Drugs and Cosmetics".

TOOL USED TO ASSESS SCORE: standard ophthalmoscope.
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Remarks:
Discharge
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
3
Irritant / corrosive response data:
No adverse corneal or iridial effects were noted. Minimal conjunctival irritation was noted in two animals one hour after treatment (score 1), this effect resolved within 24 hours. No other adverse ocular effects were noted.
Interpretation of results:
GHS criteria not met
Conclusions:
An acute eye irritation test was performed with 3 rabbits according to OECD/EC guideline. As no adverse effects were seen in the treated eyes at 24, 48 and 72 hours, PEMP was found to be not irritating to the eye.
Executive summary:

An acute eye irritation test was performed with 3 rabbits according to OECD/EC guideline. Minimal conjunctival irritation was noted in two animals one hour after treatment (score 1), this effect resolved within 24 hours.No adverse corneal or iridial effects were noted at any timepoint. No other effects were noted. Based on the results of this study, PEMP was found to be not irritating to the eye.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Two skin irritation tests are available with PEMP, both performed according to OECD/ EC guidelines and GLP principles. The results of the two tests are identical. In the first, one rabbit was exposed semi-occlusively for 3 minutes, 1 hour 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 at the 7-day observation.

In a second skin irritation test, three rabbits were exposed semi-occlusively for 4 hours. At one hour after removal of the test substance two of the three rabbits had very slight erythema (score 1). This was resolved after 24 hours. No other adverse skin effects were noted. No clinical signs were noted.

An acute eye irritation test was performed with 3 rabbits according to OECD/EC guideline. Minimal conjunctival irritation was noted in two animals one hour after treatment (score 1), this effect resolved within 24 hours.No adverse corneal or iridial effects were noted at any timepoint. No other effects were noted. Based on the results of this study, PEMP was found to be not irritating to the eye.


Justification for selection of skin irritation / corrosion endpoint:
Two reliable studies are available, the study selected as key study represents the newest study (Klimisch 1).

Justification for selection of eye irritation endpoint:
One reliable study available.

Justification for classification or non-classification

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