Registration Dossier

Administrative data

Description of key information

Skin and eye irritation are discussed

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:
weight of evidence
Study period:
1975, not specified
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Study is old data conducted to no recognised test guideline. The data are reported in a brief resume of the test and observations.
Qualifier:
according to
Guideline:
other: 16 CFR 1500.41
Deviations:
not specified
Principles of method if other than guideline:
The acute skin irritation test was conducted on 6 adult albino rabbits selected from healthy, acclimated animals. The method employed is patterned after the Draize procedure as described in 16 CFR 1500.41 . The back of each animal was shaved free of hair; intact skin was exposed on the left half of the shaved area, and the abraded on the right half. The material (0.5 ml or 0.5 g) was introduced under a square patch of surgical gauze measuring 1 inch x 1 inch. Patches were removed after 24 hours and observations recorded. Observations were again made after 72 hours.
GLP compliance:
no
Species:
rabbit
Strain:
other: Albino
Details on test animals and environmental conditions:
6 adult albino rabbits selected from healthy, acclimated animals. No other information is detailed.
Type of coverage:
semiocclusive
Preparation of test site:
other: One side shave and one side abraded.
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 ml or 0.5 g
Duration of treatment / exposure:
24 hours.
Observation period:
72 hours.
Number of animals:
6
Details on study design:
The acute skin irritation test was conducted on 6 adult albino rabbits selected from healthy, acclimated animals. The method employed is patterned after the Draize procedure as described in 16 CFR 1500.41 . The back of each animal was shaved free of hair; intact skin was exposed on the left half of the shaved area, and the abraded on the right half. The material (0.5 ml or 0.5 g) was introduced under a square patch of surgical gauze measuring 1 inch x 1 inch. Patches were removed after 24 hours and observations recorded. Observations were again made after 72 hours.
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72h
Score:
0
Max. score:
0
Reversibility:
other: no effects
Irritant / corrosive response data:
No erythema or edema were observed.
Other effects:
None

Table 1

Findings

Exposure Time (Hours)

Exposure Unit

Rabbit No

Erythema and eschar formation:

 

1

2

3

4

5

6

Intact Skin

24

0

0

0

0

0

0

 

72

0

0

0

0

0

0

Abraded Ski

24

0

0

0

0

0

0

 

72

0

0

0

0

0

0

Subtotal

 

0

0

0

0

0

0

 

 

 

 

 

 

 

 

Edema formation:

 

 

 

 

 

 

 

Intact Skin

24

0

0

0

0

0

0

 

72

0

0

0

0

0

0

Abraded Ski

24

0

0

0

0

0

0

 

72

0

0

0

0

0

0

Subtotal

 

0

0

0

0

0

0

 

 

 

 

 

 

 

 

Score

 

0

0

0

0

0

0

Average:

0.00

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
On the basis of the data presented herein, the test material, is not an irritant to the rabbit skin. This material is not considered a corrosive substance.
Executive summary:

The test sample was exposure to the backs of 6 albino rabbits; theback of each animal was previously shaved free of hair. Intact skin was exposed on the left half of the shaved area, and the abraded on the right half. No skin reactions were observed over a 72 hour review period and the test sample is considered to be non-irritating.

On the basis of the data presented herein, the test material is not an irritant to the rabbit skin . This material is not considered a corrosive substance.

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
No information.
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Study is old data conducted to no recognised test guideline. The data are reported in a brief resume of the test and observations.
Qualifier:
no guideline followed
Principles of method if other than guideline:
The corrosive skin irritation test was conducted on 6 adult albino rabbits. The back of each animal was shaved free of hair and the test material was introduced to the intact skin under surgical gauze Immediately thereafter animals were immobilized, and the entire trunk of each animal was covered with an impervious cloth. After an exposure period of 4 hours, the patches were removed and observations recorded. Observations were again made after 72 hours. The method employed is patterned after 2 1 CFR131.11 as described in 49 CFR 173.240.
GLP compliance:
no
Species:
rabbit
Strain:
not specified
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: From: To: No data.
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
not specified
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml or 0.5 g
- Concentration (if solution): No data.
Duration of treatment / exposure:
4 hours.
Observation period:
72 hours.
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 1 inch x 1 inch
- % coverage: No data.
- Type of wrap if used:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No data.
- Time after start of exposure: No data.

SCORING SYSTEM:
Erythema and Eschar formation:
No Erythema = 0
Slight Erythema = 1
Well defined Erythema = 2
Moderate to Severe Erythema = 3
Severe Erythema = 4
Slight Eschar Formation = 5
Severe Eschar Formation, Ulceration = 6
**Scores of greater than 4 indicate a corrosive effect.
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
Slight erythema was observed in one of the animals after the 4-hour exposure period. This effect cleared within 72 hours.

Table 1: Erythema and eschar formation during exposure and observation period:

 Findings

Exposure Time 

 Exposure

Unit 

 (Value)

Rabbit 

 Number

 Erythema and eschar formation

 (Hours)

 1

 Intact Skin

 4

 0

 Intact Skin

 72

Interpretation of results:
other: not corrosive.
Remarks:
Criteria used for interpretation of results: other: Title 49 CPR paragraph 173.240.
Conclusions:
The registered substance was determined not to be corrosive to the rabbit skin so the material is not considered to be a corrosive substance.
Executive summary:

The registered substance was determined not to be corrosive to the rabbit skin so the material is not considered to be a corrosive substance.

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:
No information.
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non GLP, not carried out according to recognised guideline, although results documented.
Qualifier:
according to
Guideline:
other: 16 CFR 1500.42
Deviations:
not specified
Principles of method if other than guideline:
The acute eye irritation test was determined on 9 young adult albino rabbits, selected from healthy, acclimated animals. The test material at the level of 0,1 ml or 0.1 g was applied to the right eye of each animal. The method employed was patterned after the procedure described in 16 CFR 1500.42.
The test procedure was modified as follows:
Group I: Six rabbits; eyes unwashed following the instillation of the test material.
Group II: Three rabbits; eyes washed 4 seconds following instillation of the test material.
All eyes were observed and ocular reaction recorded at 24,48, and 72 hours after instillation of the test material. They were observed again after 7 days.
GLP compliance:
no
Species:
rabbit
Strain:
other: Albino
Details on test animals or tissues and environmental conditions:
9 young adult albino rabbits, selected from healthy, acclimated animals. No other information is detailed within the report.
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0,1 ml or 0.1 g
Duration of treatment / exposure:
See below.
Observation period (in vivo):
24, 48, 72 hours and 7 days
Number of animals or in vitro replicates:
6 unwashed and 3 washed animals
Details on study design:
The acute eye irritation test was determined on 9 young adult albino rabbits, selected from healthy, acclimated animals. The test material at the level of 0,1 ml or 0. 1 g was applied to the right eye of each animal.
The method employed was patterned after the procedure described in 16 CFR 1500.42.
The test procedure was modified as follows:
Group I: Six rabbits; eyes unwashed following the instillation of the test material.
Group II: Three rabbits; eyes washed 4 seconds following instillation of the test material.
All eyes were observed and ocular reaction recorded at 24,48, and 72 hours after instillation of the test material. They were observed again after 7 days.

Irritation parameter:
overall irritation score
Basis:
animal #1
Time point:
other: 7 days
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: Unwashed eye - No effects noted
Irritation parameter:
overall irritation score
Basis:
animal #2
Time point:
other: 7 days
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: Unwashed eye - No effects noted
Irritation parameter:
overall irritation score
Basis:
animal #3
Time point:
other: 7 days
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: Unwashed eye - No effects noted
Irritation parameter:
overall irritation score
Basis:
animal #4
Time point:
other: 7 days
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: Unwashed eye - No effects noted
Irritation parameter:
overall irritation score
Basis:
animal #5
Time point:
other: 7 days
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: Unwashed eye - No effects noted
Irritation parameter:
overall irritation score
Basis:
animal #6
Time point:
other: 7 days
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: Unwashed eye - No effects noted
Irritation parameter:
overall irritation score
Basis:
animal: 7
Time point:
other: 7 days
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: Washed eye - No effects noted
Irritation parameter:
overall irritation score
Basis:
animal: 8
Time point:
other: 7 days
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: Washed eye - No effects noted
Irritation parameter:
overall irritation score
Basis:
animal: 9
Time point:
other: 7 days
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: Washed eye - No effects noted
Irritant / corrosive response data:
No ocular effects were observed in any of the animals of either group.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance is not an irritant to the rabbit eye when not followed by a washout or followed by a washout 4 seconds after instillation of the test material.
Executive summary:

The substance is not an irritant to the rabbit eye when not followed by a washout or followed by a washout 4 seconds after instillation of the test material.

No classification is applicable based on the results.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation / Corrosion.

Two studies were evaluated on this endpoint. In these, the substance was tested for primary dermal irritation and corrosiveness. Results indicate that has a potential for slight dermal irritation, although effects were reversible within 72 hours. It is not a dermal corrosive. No risk phrase or classification is required.

Eye irritation.

One study is available for this endpoint. The substance was tested for acute irritation and was found not to be an irritant to the rabbit eye when not followed by a washout or followed by a washout 4 seconds after instillation of the test material. No ocular effects were noted in the study. No classification is applicable.

Respiratory irritation was not assessed; however no effects on the animals were noted in any associated studies.

Justification for classification or non-classification

The above studies have all been ranked reliability 2 or 3 according to the Klimish et al system. This ranking was deemed appropriate because the studies were not conducted to GLP or in compliance with agreed protocols. Some of the reports do not detail a specific method; however each documents dose levels and responses in detail, so is deemed appropriate for use in the support of a formal registration.  Sufficient dose ranges and numbers are detailed; hence it is appropriate for use based on reliability and animal welfare grounds.

Justification for classification or non classification

The above results triggered no classification under the Dangerous Substance Directive (67/548/EEC) or the CLP Regulation (EC No 1272/2008).