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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:
May 2014 - August 2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report date:
2014

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 3706OB
- Expiration date of the lot/batch: 01 March 2019
- Purity test date: >99%

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature in the dark


Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: by Harlan Laboratories UK Ltd., Leicestershire, UK
- Age at study initiation: twelve to twenty weeks old
- Weight at study initiation: At the start of the study the animals weighed 2.65 or 2.80 kg
- Housing: suspended cages
- Diet / water: Free access to mains drinking water and food was allowed throughout the study
- Acclimation period: at least five

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23 °C
- Humidity (%): 30 to 70%
- Air changes (per hr): at least fifteen changes
- Photoperiod (hrs dark / hrs light): lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 g of the test item

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL of distilled water

resulting to a 10% w/w aqueous preparation of the test item

Duration of treatment / exposure:
Duration of treatment: 3 minutes, 1 hour and 4 hours after application.
Observation period:
72 hours after exposure
Number of animals:
2 animals
The number of animals used was the minimum required to achieve the objectives of the study. Testing was conducted on two animals and the response in these animals was such that exposure of a third animal would not affect classification of the test item, therefore no further testing was needed.
Details on study design:
TEST SITE
- Area of exposure: 3

REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:

OBSERVATION TIME POINTS
Immediately following removal of the patches (3 minutes, 1 hour and 4 hours) and approximately 1, 24, 48 and 72 hours later

SCORING SYSTEM:
- Method of calculation: Calculation of Primary Irritation Index and Grading of Irritancy Potential Using the Draize Scheme

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
24/48/72 h
Score:
0
Irritant / corrosive response data:
Skin irritation:
- 3-Minute Exposure Period: No evidence of skin irritation was noted during the study. (See table 1 in "Any other information on results incl. tables)
- 1-hour Exposure Period: No evidence of skin irritation was noted during the study.(See table 1 in "Any other information on results incl. tables)
- 4-hour Exposure Period: No evidence of skin irritation was noted during the study.(See table 2 in "Any other information on results incl. tables)

Body Weight: Both animals showed expected gain in body weight during the study. (See table 3 in "Any other information on results incl. tables)
Other effects:
Measurement of pH:
10% w/w aqueous preparation of the test item immediately after preparation = 7.33
10% w/w aqueous preparation of the test item ten minutes after preparation = 7.33

Any other information on results incl. tables

Table 1 :   Individual Skin Reactions Following 3-Minute and 1-Hour Exposures

Skin Reaction

Observation Time

(following patch

removal)

Individual Scores

Rabbit Number and Sex

74487 Female

 

 

3-Minute

Exposure

1-Hour

Exposure

Erythema/Eschar Formation

Immediately

0

0

 

1 Hour

0

0

 

24 Hours

0

0

 

48 Hours

0

0

 

72 Hours

0

0

Edema Formation

Immediately

0

0

 

1 Hour

0

0

 

24 Hours

0

0

 

48 Hours

0

0

 

72 Hours

0

0

Table 2 :   Individual Skin Reactions Following 4-Hour Exposure

Skin Reaction

 

 

 

Observation Time (following patch removal)

 

 

 

Individual Scores

 Total

 

 

Rabbit Number and Sex

 

 

 

74487 Female

74520 Female

Erythema/Eschar Formation 

Immediately

0

0

(0)

 

1 Hour

0

0

(0)

 

24 Hours

0

0

0

 

48 Hours

0

0

(0)

 

72 Hours

0

0

0

Edema Formation 

Immediately

0

0

(0)

 

1 Hour

0

0

(0)

 

24 Hours

0

0

0

 

48 Hours

0

0

(0)

 

72 Hours

0

0

0

Sum of 24 and 72-Hour Readings (S) = 0                                                                         

Primary Irritation Index (S/4) : 0/4 = 0.0

 Classification:         NON-IRRITANT

( ) =   Total values not used for calculation of primary irritation index

Table 3:    Individual Body Weights and Body Weight Change

Rabbit

Number and Sex 

Individual Body Weight (kg)

Body Weight Change (kg)

 

Day 0

Day 3

 

74487 Male

2.80

2.95

0.15

74520 Male

2.65

2.74

0.09

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item produced a primary irritation index of 0.0 and was classified as non-irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
The test item does not meet the criteria for classification according to Regulation (EC) No 1272/2008, relating to the Classification, Labelling and Packaging of Substances and Mixtures and the Globally Harmonized System of Classification and Labelling of Chemicals.
Executive summary:

The dermal irritancy potential of the test item following single, 3-Minute, 1 and 4-Hour, semi-occluded applications to the intact rabbit skin was assessed according to the OECD Guidelines for  the Testing of Chemicals No.404  "Acute  Dermal Irritation/Corrosion" (adopted 24 April 2002). The study was conducted in compliance with the principles of Good Laboratory Practice.

At each test site a quantity of 0.5 g of the test item, moistened sufficiently with 0.5 mL of distilled water to achieve a paste, was introduced under a 2.5 cm x 2.5 cm cotton gauze patch on three suitable sites selected on the back of the rabbit.

3-Minute and 1-Hour semi-occluded applications of the test item to the intact skin of one rabbit produced no evidence of skin irritation. A single 4-Hour, semi occluded application of the test item to the intact skin of two rabbits produced no evidence of skin irritation.

The test item produced a primary irritation index of 0.0 and was classified as non-irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.

The test item, Reaction mass of AminoPhosphonium salt and BisphenolAF, does not meet the criteria laid down in CLP; Regulation (EC) No 1272/2008, relating to the Classification, Labelling and Packaging of Substances and Mixtures and the Globally Harmonized System of Classification and Labelling of Chemicals.