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Diss Factsheets

Administrative data

Description of key information

skin irritation (OECD 439), rabbit: not-irritating
eye irritation (OECD 437), rabbit: not-irritating

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:
17 - 20 Jul 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the appropriate OECD test guideline and in compliance with GLP.
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
(2002)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
(2008)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
The Department of Health of the Government of the United Kingdom
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories UK, Ltd., Leicestershire, UK
- Age at study initiation: 12 - 20 weeks
- Weight at study initiation: 2340 – 2760 g
- Housing: Animals were caged individually in suspended cages
- Diet: 2930C Teklad Global Certified Rabbit diet (Harlan Laboratories UK, Ltd., Oxon, UK), ad libitum
- Water: (tap/filtered) water, ad libitum
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated sites of the same animal served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
4 h
Observation period:
3 days
Reading time points: 1, 24, 48 and 72 h
Number of animals:
2 males
Details on study design:
TEST SITE
- Area of exposure: 6.25 cm² on one site of the dorsal/flank area
Type of wrap if used: The test item was introduced under a 2.5 x 2.5 cm cotton gauze patch. The patch was secured in position with a strip of surgical adhesive tape. The trunk of each rabbit was wrapped in an elasticated corset.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Four hours after application the corset and patches were removed from each animal and any residual test item removed by gentle swabbing with cotton wool soaked in distilled water.
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize scoring system
Irritation parameter:
erythema score
Basis:
other: mean of 2 animals
Time point:
other: mean over 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
edema score
Basis:
other: mean over 2 animals
Time point:
other: mean over 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritant / corrosive response data:
Very slight erythema was noted at both treated skin sites immediately and one hour after patch removal. Very slight edema was also noted at one treated skin site immediately after patch removal. Both treated skin sites appeared normal at the 24-hour observation time point.
Other effects:
Both animals showed expected gain in bodyweight during the study.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
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:
30 Jul - 09 Aug 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the appropriate OECD test guideline and in compliance with GLP.
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
(2002)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
(2008)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
The Department of Health of the Government of the United Kingdom
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories UK, Ltd., Leicestershire, UK
- Age at study initiation: 12 - 20 weeks
- Weight at study initiation: 2600 – 2920 g
- Housing: Animals were caged individually in suspended cages
- Diet: 2930C Teklad Global Certified Rabbit diet (Harlan Laboratories UK, Ltd., Oxon, UK), ad libitum
- Water: (tap/filtered) water, ad libitum
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
single application without washing
Observation period (in vivo):
3 days
Reading time points: 1, 24, 48 and 72 h
Number of animals or in vitro replicates:
2 males
Details on study design:
SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: light source from a standard ophthalmoscope
Irritation parameter:
cornea opacity score
Basis:
other: mean over 2 animals
Time point:
other: mean over 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
iris score
Basis:
other: mean over 2 animals
Time point:
other: mean over 24, 48 and 72 hours
Score:
0
Max. score:
2
Reversibility:
other: reversibility: not applicable
Irritation parameter:
chemosis score
Basis:
other: mean over 2 animals
Time point:
other: mean over 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 hours
Score:
0
Max. score:
3
Reversibility:
other: reversibility: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 hours
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritant / corrosive response data:
Neither corneal nor iris effects were noted after application with the test material during the study period. Moderate conjunctival irritation was noted in one treated eye with minimal conjunctival irritation period noted in the other treated eye one hour after treatment. Minimal conjunctival irritation was noted in one treated eye at the 24-hour observation time point. One treated eye appeared normal at the 24-hour observation time point abd the other treated eye appeared normal at the 48-hour observation time point.
Other effects:
No mortalities occured during the study period. One animal showed bodyweight loss and the other animal showed expected gain in bodyweight during the study.

Table 1: Individual scores for occular irritation

Rabbit #

 

Time [h]

 

conjunctivae

 

iris

 

cornea

 

redness

swelling

1

 

 

 

 

1

1

1

0

0

24

0

0

0

0

48

0

0

0

0

72

0

0

0

0

average

0

0

0

0

2

 

 

 

 

1

2

1

0

0

24

1

0

0

0

48

0

0

0

0

72

0

0

0

0

average

0.33

0

0

0

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation/corrosion

A reliable key skin irritation study with Didocosyl sebacate (CAS 42233-75-0) is available and was performed according to OECD TG 404 and in compliance with GLP (Sanders, A., 2012c). In the study two male New Zealand White rabbits were exposed to 0.5 g of the neat test material for 4 hours applied onto the clipped skin via semi-occlusive dressing. Skin reactions were evaluated 1, 24, 48 and 72 hours post-application. No mortalities occurred and no remarkable body weight changes were observed during the study period. The test material induced very slight erythema at both treated skin sites immediately and one hour after patch removal and a very slight edema at one treated animal immediately after patch removal. All observed skin reactions were fully reversible within 24 hours post-application. Based on the results of the study the test item should be considered as non-irritating.

 

Eye irritation

A reliable key eye irritation study with Didocosyl sebacate (CAS 42233-75-0) is available and was performed according to OECD TG 405 and in compliance with GLP (Sanders, A., 2012d). For the assessment of the eye irritation properties 0.1 mL of the test substance was instilled in the eye of two male New Zealand White rabbits. The eyes were examined and the changes were graded according to the Draize scoring system 1, 24, 48 and 72 hours post-application. No mortalities occurred during the study period. One animal showed bodyweight loss and the other animal showed expected gain in bodyweight during the observation period. Neither corneal nor iris effects were noted after application with the test material during the study period. Slight redness (grade 1-2) and chemosis (grade 1) were observed in both animals 1 h after instillation of the test substance. The observed effects were fully reversible in both animals within 24 and 48 hours, the calculated mean values of conjunctivae irritation were 0 and 0.33, respectively. Mean chemosis values were 0 in both animals. Based on the results of the study the test item should be considered as non-irritating.


Justification for selection of skin irritation / corrosion endpoint:
The reliable GLP compliant OECD Guideline study was choosen.

Justification for selection of eye irritation endpoint:
The reliable GLP compliant OECD Guideline study was choosen.

Justification for classification or non-classification

The available data on skin and eye irritation of the registered substance do not meet the criteria for classification according to Regulation (EC) No 1272/2008, and are therefore conclusive but not sufficient for classification.