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Diss Factsheets

Administrative data

Description of key information

In the key in vivo skin irritation study in rabbits according to OECD guideline 404 and GLP, no skin irritation was observed under the conditions of the study.


 


In the key in vivo eye irritation study in rabbits according to OECD guideline 405, the test item was found to be non-irritating to the eyes.

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
No mentioning of clinical and body weight observations, irritation readings only after 24 and 72 hours
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1981
Deviations:
yes
Remarks:
No mentioning of clinical and body weight observations, irritation readings only after 24 and 72 hours
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Remarks:
Albino rabbits
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: Not specified
- Weight at study initiation: 3.0 kg (average)
- Housing: Individually
- Diet: Ad libitum (Altromin standard diet for rabbits)
- Water: Ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 2
- Humidity (%): 50-60
- Air changes (per hr): Not specified
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From day 0 to day 7
Type of coverage:
occlusive
Preparation of test site:
shaved
Remarks:
Shaved and scarified
Vehicle:
unchanged (no vehicle)
Remarks:
The test item was used undiluted and applicated dermally after warmed up in a waterbath.
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 g
Duration of treatment / exposure:
24 hours
Observation period:
After 24 hours (directly after removing the patch) and after 72 hours. After 7 days, localizations were controlled finally.
Number of animals:
5 animals
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm^2
- Type of wrap: Cellulose patch which was fixed by means of leucoplast. All the trunk of the animals was wrapped with a rubber cloth for 24 hours.

OBSERVATION TIME POINTS
24 hours, 72 hours and 7 days after start of treatment

SCORING SYSTEM:
- Method of calculation: According to Draize (1959, see "Any other information on materials and methods incl. tables). Substances with an index of primary irritation of 2 or less are no to mild stimulating substances, those with an index of 2 to 5 moderate ones and those with an index of 5 more are strong stimulants.
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no irritation observed
Remarks on result:
no indication of irritation
Remarks:
Irritation was only checked at 24 and 72 hours.
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no irritation observed
Remarks on result:
no indication of irritation
Remarks:
Irritation was only checked at 24 and 72 hours.
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no irritation observed
Remarks on result:
no indication of irritation
Remarks:
Irritation was only checked at 24 and 72 hours.
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no irritation observed
Remarks on result:
no indication of irritation
Remarks:
Irritation was only checked at 24 and 72 hours.
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no irritation observed
Remarks on result:
no indication of irritation
Remarks:
Irritation was only checked at 24 and 72 hours.
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no irritation observed
Remarks on result:
no indication of irritation
Remarks:
Irritation was only checked at 24 and 72 hours.
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no irritation observed
Remarks on result:
no indication of irritation
Remarks:
Irritation was only checked at 24 and 72 hours.
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no irritation observed
Remarks on result:
no indication of irritation
Remarks:
Irritation was only checked at 24 and 72 hours.
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no skin irritation observed
Remarks on result:
no indication of irritation
Remarks:
Irritation was only checked at 24 and 72 hours.
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no irritation observed
Remarks on result:
no indication of irritation
Remarks:
Irritation was only checked at 24 and 72 hours.
Other effects:
- Other adverse local effects: No
- Other adverse systemic effects: No
Interpretation of results:
GHS criteria not met
Conclusions:
In an in vivo skin irritation study in rabbits according to OECD guideline 404 and GLP, no skin irritation was observed under the conditions of the study.
Executive summary:

The test compound was tested undiluted in a primary skin irritation test in rabbits according to OECD 404 and GLP. No irritation could be observed after 24 and 72 hours under the conditions of the study. The index of primary irritations (mean of 24- and 72-hour values) was 0, therefore the compound is considered to be non-irritant. After 7 days, the skin of the animals was checked again and no signs of irritation was observed. 

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:
1986-07-21 to 1986-07-24
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Remarks:
Albino rabbits
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: Young adult
- Weight at study initiation: 2.5-3.0 kg
- Housing: Individually in suspended, galvanized cages, fitted with wire-mesh floor and front
- Diet: Ad libitum
- Water: Ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 + 3
- Humidity (%): At least 40
- Air changes (per hr): Approx. 10
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From day 0 to day 3
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 mL of melted test substance, cooled down to 30°C
Duration of treatment / exposure:
The eyes were not washed out following administration, thus animals were exposed to the test substance for the full observation period of 72 hours.
Observation period (in vivo):
72 hours (effects were scored after 24, 48 and 72 hours)
Number of animals or in vitro replicates:
Three male animals were treated with a single concentration
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: No

SCORING SYSTEM: According to Draize (see "Any other information on materials and methods incl. tables")
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 24 hours
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 24 hours
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 24 hours
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: No effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: No effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: No effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: No effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: No effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: No effects observed
Remarks on result:
no indication of irritation
Interpretation of results:
GHS criteria not met
Conclusions:
In an in vivo eye irritation study in rabbits according to OECD guideline 405, the test item was found to be non-irritating to the eyes.
Executive summary:

In an eye irritation study according to OECD guideline 405 and GLP, the test item was examined undiluted for acute eye irritation/corrosion in three albino rabbits. Eye effects were examined after one hour, and after 24, 48 and 72 hours and scored according to the Draize scala. The test substance caused slight eye effects in all (three) rabbits 1 hour after treatment (slight redness and slight swelling of the conjunctivae) which was graded with a score of 1. After 24 hours, all eye effects had cleared completely (score of 0). The overall 24/48/72 hour score was 0 for corneal opacity, iris, and redness or chemosis of the conjunctivae. On the basis of the results obtained, it was concluded that the undiluted test substance is not an eye irritant and not corrosive to eyes.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Key, Skin irritation in vivo, RL2


The test compound was tested undiluted in a primary skin irritation test in rabbits according to OECD 404 and GLP. No irritation could be observed after 24 and 72 hours under the conditions of the study. The index of primary irritations (mean of 24- and 72-hour values) was 0, therefore the compound is considered to be non-irritant. After 7 days, the skin of the animals was checked again and no signs of irritation were observed. 


 


Key, Eye irritation in vivo, RL1


In an eye irritation study according to OECD guideline 405 and GLP, the test item was examined undiluted for acute eye irritation/corrosion in three albino rabbits. Eye effects were examined after one hour, and after 24, 48 and 72 hours and scored according to the Draize scala. The test substance caused slight eye effects in all (three) rabbits 1 hour after treatment (slight redness and slight swelling of the conjunctivae) which was graded with a score of 1. After 24 hours, all eye effects had cleared completely (score of 0). The overall 24/48/72 hour score was 0 for corneal opacity, iris, and redness or chemosis of the conjunctivae. On the basis of the results obtained, it was concluded that the undiluted test substance is not an eye irritant and not corrosive to eyes.

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data, the test item is not classified and labelled for skin and eye irritation according to Regulation (EC) No 1272/2008 (CLP), as amended for the eighteenth time in Regulation (EU) 2022/692.