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Administrative data

Description of key information

Skin irritation

The Primary Irritation Index (PII) of CR SB37 was 0 and CR SB37 was categorized as non-irritant (OECD TG404).

 

Eye irritation

CR SB37 was not any irritant to the eye (OECD TG405).

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:
From October 3, 2017 to March 6, 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
- Source: Lohas
- Weight at study initiation: above 2.0 kg
- Housing: one rabbit per cage
- Water: ad libitum
- Acclimation period: 7 days
- Temperature (°C): 21 ± 2 °C
- Humidity (%): 55 ± 15%
- Photoperiod: 12hrs dark / 12hrs light
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
physiological saline
Controls:
yes, concurrent vehicle
Amount / concentration applied:
- Amount(s) applied (volume or weight with unit): 0.5 g test article was moistened with 0.5 mL physiological saline
Duration of treatment / exposure:
4 hours
Observation period:
1, 24,48 and 72 hours
Number of animals:
Three
Details on study design:
- Area of exposure: upper left and lower right dorsal area
- Washing (if done): with distilled water
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation

Table 1. The body weight of the rabbits during the study period

Animal ID

Sex

Body weight (kg)

Day 1

Day 4

180

Male

2.86

2.90

181

Male

3.12

3.13

182

Male

2.85

2.92

Table 2. The results of rabbit skin irritation response

Animal I.D.

Observation time (hours)

Skin grading (erythema / edema)

Test area

Control area

180

1

0/0

0/0

0/0

0/0

24± 1

0/0

0/0

0/0

0/0

48 ± 1

0/0

0/0

0/0

0/0

72 ± 1

0/0

0/0

0/0

0/0

181

1

0/0

0/0

0/0

0/0

24 ± 1

0/0

0/0

0/0

0/0

48 ± 1

0/0

0/0

0/0

0/0

72 ± 1

0/0

0/0

0/0

0/0

182

1

0/0

0/0

0/0

0/0

24 ± 1

0/0

0/0

0/0

0/0

48 ± 1

0/0

0/0

0/0

0/0

72 ± 1

0/0

0/0

0/0

0/0

Table 3. Primary irritation scores of rabbit skin irritation test

Animal I.D.

Irritation scoresa

Primary Irritation Scores (PIS)b

Test area

Control area

180

0

0

0

181

0

0

0

182

0

0

0

Primary Irritation Index (PII)c= 0

a Irritation scores were the sum of each rabbit irritation values at three time points and then divided by the total number of observation.

b PIS = (scores of test area) – (scores of control area).

c PII = Sum of PIS÷number of animals.

Interpretation of results:
GHS criteria not met
Conclusions:
According to OECD 404 test method and Evaluation table for single dermal irritation, the PII for CR SB37 was 0 and CR SB37 was categorized as non-irritant. Therefore, CR SB37 was not met a category based on GHS criteria.
Executive summary:

This test using the procedures outlined in the SuperLab Study Plan for M62-170900008002EN which is based on the SOP for the OECD 404 (SOPP-305) and OECD 404 (OECD, 2015). The sites were grades for erythema and edema at 1, 24, 48 and 72 hours after the patches removal.No clinical signs of toxicity were found. Body weight changes were within the normal range in all animals. All animals was no formation of erythema, eschar or edema on the test area within 72 hours after patch removal. The Primary Irritation Index for CR SB37 was calculated to be 0. On the basis of the test results given above and according toEvaluation table for single dermal irritation, the response of CR SB37 was categorized as non-irritant.

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:
From October 03, 2017 to March 06, 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
- Source: Lohas
- Weight at study initiation: above 2.0 kg
- Housing: one animal per cage
- Water: ad libitum
- Acclimation period: 7 days
- Temperature (°C): 21 ± 2 °C
- Humidity (%): 55 ± 15%
- Photoperiod: 12-hrs dark / 12-hrs light
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
- Amount(s) applied (volume or weight with unit): 0.1 g
Duration of treatment / exposure:
1 hours
Observation period (in vivo):
1, 24, 48 and 72 hours
Number of animals or in vitro replicates:
Three
Irritation parameter:
cornea opacity score
Basis:
animal: #177, #178 and #179
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal: #177, #178 and #179
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal: #177, #178 and #179
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal: #177, #178 and #179
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation

Table 1. Body weight of the rabbits

Animal ID

Sex

Body weight (kg)

Day 1

Day 4

177

Male

3.02

3.10

178

Male

2.89

2.93

179

Male

2.70

2.80

Table 2. Eye response of the eye irritation test

Animal I.D.

Timea (hour)

Group

Grades of the irritation reaction

Cornea

Conjunctivae

Iris

Opacity

Area

Redness

Chemosis

Discharge

177

1

Testb

0

0

0

0

0

0

Controlc

0

0

0

0

0

0

24 ± 1

Test

0

0

0

0

0

0

Control

0

0

0

0

0

0

48 ± 1

Test

0

0

0

0

0

0

Control

0

0

0

0

0

0

72 ± 1

Test

0

0

0

0

0

0

Control

0

0

0

0

0

0

178

1

Test

0

0

0

0

0

0

Control

0

0

0

0

0

0

24 ± 1

Test

0

0

0

0

0

0

Control

0

0

0

0

0

0

48 ± 1

Test

0

0

0

0

0

0

Control

0

0

0

0

0

0

72 ± 1

Test

0

0

0

0

0

0

Control

0

0

0

0

0

0

179

1

Test

0

0

0

0

0

0

Control

0

0

0

0

0

0

24 ± 1

Test

0

0

0

0

0

0

Control

0

0

0

0

0

0

48 ± 1

Test

0

0

0

0

0

0

Control

0

0

0

0

0

0

72 ± 1

Test

0

0

0

0

0

0

Control

0

0

0

0

0

0

a Observation time was started after application of the test article

b Left eye of the test rabbits

c Right eye of the test rabbits

Interpretation of results:
GHS criteria not met
Conclusions:
According to OECD 405 test method, CR SB37 showed that no irritant to the eye. Therefore, CR SB37 was not met a category based on GHS criteria.
Executive summary:

This test using the procedures outlined in the SuperLab Study Plan for M62-170900009002EN which is based on the SOP for the OECD 405 (SOPP-306) and OECD 405 (OECD, 2012). There were no test article effects on body weight. CR SB37 was given by a single ocular application at 0.1 g amount toNZW male rabbits and followed by ocular examination within 72 hours. Three rabbits did not show any eye irritation response after application of CR SB37 and irritation responses were 0. On the basis of the test results given above, the response of CR SB37 was not any irritant to the eye.

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

Additional information

Skin irritation

The sites were grades for erythema and edema at 1, 24, 48 and 72 hours after the patches removal.No clinical signs of toxicity were found. Body weight changes were within the normal range in all animals. All animals was no formation of erythema, eschar or edema on the test area within 72 hours after patch removal. The Primary Irritation Index for CR SB37 was calculated to be 0. On the basis of the test results given above and according toEvaluation table for single dermal irritation, the response of CR SB37 was categorized as non-irritant.

 

Eye irritation

There were no test article effects on body weight. CR SB37 was given by a single ocular application at 0.1 g amount toNZW male rabbits and followed by ocular examination within 72 hours. Three rabbits did not show any eye irritation response after application of CR SB37 and irritation responses were 0. On the basis of the test results given above, the response of CR SB37 was not any irritant to the eye.

Justification for classification or non-classification

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