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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Skin irritation: In vivo skin irritation study, New Zealand White rabbit, m/f, 500 µl/animal, 24h exposure, undiluted substance: not irritating
Skin irritation: In vivo skin irritation study, New Zealand White rabbit, m/f, 500 µl/animal, 24h exposure, 50% solution: not irritating
Eye irritation: In vivo eye irritation study, New Zealand White rabbit, m/f, 100 µl/eye, no wash-out, undiluted substance: not irritating
Eye irritation: In vivo eye irritation study, New Zealand White rabbit, m/f, 100 µl/eye, no wash-out, 50% solution: 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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Scientifically reasonable study on the registered substance itself with some deficiencies in documentation. However, given data indicate that the study was well-performed.
Principles of method if other than guideline:
Test item was applied for 24h to the inner side of the ear of two rabbits, post-observation period was 7 days after washing.
GLP compliance:
no
Remarks:
study performed prior to GLP implementation
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Sex: male/female
- Weight at study initiation: 3-4 kg
- Housing: individually
Type of coverage:
semiocclusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 µl/animal
Duration of treatment / exposure:
24h
Observation period:
7 days
Number of animals:
2
Details on study design:
TEST SITE
- Area of exposure: inner side of the ear
- Type of wrap if used: adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water and soap / vegetal oil
- Time after start of exposure: 24h
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: mean Day 0 and 2 postobservation
Score:
0.5
Max. score:
1
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Score:
0.5
Max. score:
1
Reversibility:
not specified
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
48 h
Score:
1
Max. score:
1
Reversibility:
not specified
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
48 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
48 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
48 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Interpretation of results:
GHS criteria not met
Conclusions:
The study was conducted with a scientifically reasonable study design on the registered substance itself with some deficiencies in documentation. However, the given data indicate that the study was well performed. Hence, the results can be considered as sufficiently reliable to assess the irritating potential of the test item towards rabbits. The results indicate that the substance is not irritating to rabbit skin and no classification as skin irritant according to Regulation 1272/2008 is triggered.
Executive summary:

In a primary dermal irritation study, two New Zealand White rabbits (m/f) were dermally exposed to 500µl of the undiluted test item for 24h hours to the inner side of the ear.  Animals then were observed for 7 days.

Maximum score was observed at day 2 post observation (1). In this study, the test item is not a dermal irritant, no classification is needed.

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Scientifically reasonable study on the registered substance itself with some deficiencies in documentation. However, given data indicate that the study was well-performed.
Principles of method if other than guideline:
Test item was applied to the conjunctival sac of two rabbits, post-observation period was 7 days.
GLP compliance:
no
Remarks:
study performed prior to GLP implementation
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Sex: male/female
- Weight at study initiation: 3-4 kg
- Housing: individually
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100µl
Duration of treatment / exposure:
7 days (no wash-out after application denoted)
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
2
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: mean 1, 2, 3, 7 days
Score:
2
Reversibility:
fully reversible within: 2 days
Remarks on result:
other: not irritating
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Interpretation of results:
GHS criteria not met
Conclusions:
The study was conducted with a scientifically reasonable study design on the registered substance itself with some deficiencies in documentation. However, the given data indicate that the study was well performed. Hence, the results can be considered as sufficiently reliable to assess the irritating potential of the test item towards rabbits. The results indicate that the substance is not irritating to the rabbit eye and no classification as eye irritant according to Regulation 1272/2008 is triggered.
Executive summary:

In a primary eye irritation study, 100µl of the undiluted test item was instilled into the conjunctival sac of the eye of two New Zealand White rabbits (m/f). Animals then were observed for 7 days.

In this study, the test item is not an eye irritant and does not need to be classified.

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

Additional information

There are each two studies available assessed with Klimisch 2 for skin and eye irritation, either with 100% of the registered substance or as test material containing 50% of the registered substance. The studies were not performed according to the latest OECD guidelines, but the studies were conducted with a scientifically reasonable study design on the registered substance itself (or 50% solution) with some deficiencies in documentation, and the given data indicate that the study was well performed. Hence, the results can be considered as sufficiently reliable to assess the irritating potential of the test item towards rabbits, either skin or eye. Also, in vivo methods can be considered to mimick human exposure more precisely than the current in vitro methods, leaving no doubt that the results are not relevant for human risk assessment. The tonnage-driven data requirements under REACH are fully met as all studies are in vivo results. All studies consistently reveal that there is no need to classify the test item as irritating to skin or eye. The database is hence of good quality, no data gaps were identified, and the substance can hence be considered as neither irritating tot he skin or eye during human risk assessment


Justification for selection of skin irritation / corrosion endpoint:
More detailed study report available, test performed on 100% of the registered substance instead of 50%.

Justification for selection of eye irritation endpoint:
More detailed study report available, test performed on 100% of the registered substance instead of 50%.

Justification for classification or non-classification

The available data (all studies assessed with Klimisch 2) consistently revealed that the substance does not induce even undiluted any relevant signs of irritiation, neither for skin nor eye, and does hence not trigger the need for classification as skin or eye irritant.