Registration Dossier

Administrative data

Description of key information

The registered substance is not irritating to skin and eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study was performed pre-GLP and pre-guideline. The report is very concise. No data on test item composition or purity. The exposure was for a period of 24-hours and under occlusion. The test substance was not moistened to ensure optimal contact with the skin. However in 6 animals the skin was abraded and no reaction occured. Therefor the negative outcome of this test is acceptable.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no
Remarks:
pre-GLP
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: No data
- Age at study initiation: No data
- Weight at study initiation: No data
- Housing: No data
- Diet (e.g. ad libitum): No data
- Water (e.g. ad libitum): No data
- Acclimation period: No data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data

IN-LIFE DATES: No data
Type of coverage:
occlusive
Preparation of test site:
other: intact and abraded, both clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
Duration of treatment / exposure:
24 hours
Observation period:
24 and 72 hours after application the skin reaction is scored.
Number of animals:
12, 6 with intact skin and 6 with abraded skin
Details on study design:
TEST SITE
- Area of exposure: back
- % coverage: 1x1 inch
- Type of wrap if used: The patches are fixed to the application site by means of adhesive tape and the entire trunk of the rabbits is wrapped. with an impervious material

REMOVAL OF TEST SUBSTANCE: the test substance is removed, no further details.
- Washing (if done):
- Time after start of exposure:

SCORING SYSTEM: Draize
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
all animals
Time point:
other: 24-72 hours after application
Score:
0
Max. score:
4
Irritant / corrosive response data:
No skin reaction observed
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No effects on the skin were observed.
Executive summary:

12 new zealand white rabbits were exposed to the test substance for 24 hours under occulsion on thier backs. 6 animals has abraded skin and 6 animals had intact skin. 24 and 72 hours after application no effects on the skin were observed.

Endpoint:
skin irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was performed pre-GLP and pre-guideline. The report is very concise. No data on test item composition or purity.
Qualifier:
no guideline available
Principles of method if other than guideline:
In general the techniques of tests as published by the FDA of the United States (Fed. Reg. (119), 5582, 1963) and Draize and Kelley (Drug Cooset. Industr. 11 (1952) 36) are followed.
GLP compliance:
no
Remarks:
pre-GLP
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: no data
- Housing: caged individually
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

IN-LIFE DATES: no data
Vehicle:
unchanged (no vehicle)
Controls:
other: The other eye, remaining untreated, serves as a control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg
Duration of treatment / exposure:
single exposure, no washing
Observation period (in vivo):
The eyes are examined at 24, 48, 72 hours and 7 days after instillation of the test material.
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): None

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: binocular ( text cannot be read) with UV illumination
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
all animals
Time point:
other: 24-48-72 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
all animals
Time point:
other: 24-48-72 hours
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
all animals
Time point:
other: 24-48-72 hours
Score:
0.66
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
all animals
Time point:
other: 24-48-72 hours
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
The eye lesions caused by the test substance were of a slight degree, see table.
Other effects:
None

Summary of ocular lesions mean of 6 animals per group 

Animal

Effect

Time after application

Average 24/48/72h 

24 h

48 h

72 h

7 d

 

7

Cornea

Iris

Redness

Chemosis

0

0

1

1

0

0

1

0

0

0

0

0

0

0

0

0

0

0

0.66

0

8

Cornea

Iris

Redness

Chemosis

0

0

1

1

0

0

1

1

0

0

1

0

0

0

0

0

0

0

1

0.66

9

Cornea

Iris

Redness

Chemosis

0

0

1

1

0

0

1

0

0

0

0

0

0

0

0

0

0

0

0.66

0.33

10

Cornea

Iris

Redness

Chemosis

0

0

< 2

1

0

0

1

0

0

0

0

0

0

0

0

0

0

0

1

0.33

11

Cornea

Iris

Redness

Chemosis

0

0

> 1

1

0

0

1

0

0

0

0

0

0

0

0

0

0

0

0.66

0.33

12

Cornea

Iris

Redness

Chemosis

0

0

< 2

1

0

0

1

1

0

0

1

0

0

0

0

0

0

0

1.33

0.66

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The eye lesions caused by the test substance were of a slight degree and do not require classification for eye irritation.
Executive summary:

Eight chemical products, all organic peroxides, were examined for eye irritating properties in experiments with albino rabbits. All products examined caused ocular lesions. Based on the effects the test substance is not classified.

Endpoint:
eye irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The registered substance is not irritating to skin and eyes.

Justification for selection of skin irritation / corrosion endpoint:

K2: The study was performed pre-GLP and pre-guideline. The report is very concise. No data on test item composition or purity. The exposure was for a period of 24-hours and under occlusion. The test substance was not moistened to ensure optimal contact with the skin. However in 6 animals the skin was abraded and no reaction occured. Therefor the negative outcome of this test is acceptable..

Justification for selection of eye irritation endpoint:

K2: The study was performed pre-GLP and pre-guideline. The report is very concise. No data on test item composition or purity.

Justification for classification or non-classification

Based on the results an in vivo skin and eye irritation study in rabbits, the data is conclusive but not sufficient for classification for these endpoints.