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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study according to GLP.
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
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland
- Weight at study initiation: 2.0, 1.9 and 2.0 kg
- Housing: Individual metal wire caging
- Diet: Altromin 2023, ad libitum
- Water): tap water via automatic watering system, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Mean 18.6 °C
- Humidity (%): average of 55 %
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
not required
Amount / concentration applied:
Amount applied: 0.5 g test substance moistened with 1 mL deionised water, applied to an area of 25 x 25 mm.
Duration of treatment / exposure:
4 hours.
Observation period:
Skin was observed at 1, 24, 48 and 72 hours after dressing removal.
Number of animals:
3 females.
Details on study design:
Skin examinations:
The skins of the animals were examined for local alterations one day before the administration of the test substance (after clipping of the hair) and immediately before the administration. The treated areas of the animals were examined for erythema/eschar and oedema as well as for other local alterations approximately 1, 24, 48 and 72 hours after patch removal.

General examinations:
The animals were examined once daily for other than local changes of the skin.
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
All areas treated with the test substance and all control areas were normal before the application and at each observation time.
Other effects:
General signs of toxicity: No signs of systemic toxicity were observed.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
All areas treated with the test substance and all control areas were normal before the application and at each observation time.
Executive summary:

A skin irritation test was performed according to OECD and EU test methods. Three female rabbits were exposed to the test substance for 4 hours.

All areas treated with the test substance and all control areas were normal before the application and at each observation time. The test substance is not a skin 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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: A study according to the EU and OECD methods, including GLP.
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
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River Germany
- Age at study initiation: ca. 9 weeks.
- Weight at study initiation: 2.1 - 2.4
- Housing: single caging
- Diet: Altromin 2123, ad libitum
- Water: Tap water ad libitum
- Acclimation period: >= 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): average of 19.5
- Humidity (%): average of 50.4
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
Equivalent to 0.1 mL: 40 - 45 mg.
Duration of treatment / exposure:
Once.
Observation period (in vivo):
1, 24, 48, 72 h and 7 d p.a.
Number of animals or in vitro replicates:
3.
Details on study design:
Prior to starting the eye irritation/corrosion study the pH-value of the test substance was determined. Substances with a pH < 2.0 and pH > 11.5 need not to be tested for acute eye irritation/corrosion.
The test substance was administered first to one animal. As no evidence for a serious damage to the eye of this animal was found during the initial 72 hour observation period (no corrosive effect), the test substance was administered to the other two animals subsequently.

The approximate equivalent of 0.1 mL of the test substance was administered per animal into the conjunctival sacs of the right eyes by gently pulling the lower lids away from the eyeballs for instillation. The eyes were held closed for about one second to prevent a loss of test substance. The left eyes remained untreated and served as a control.
The whole eyes, especially the corneae, the irises and the conjunctivae were examined, using an otoscope lamp.
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 24 h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
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:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 24 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 24 h
Irritant / corrosive response data:
The untreated eyes ("control eyes") were normal at each observation time.
The eyes, treated with the test substance ("test eyes") were normal before the instillation. After the instillation of the test substance, the following findings were made:
Corneae: Not affected at any examination term.
Irises: Not affected at any examination term.
Conjunctivae, redness: A score of "1" in 2/3 animals from 1 h p.a. until a maximum of score 1 for each animal at 24 h p.a. No irritation was observed afterwardsConjunctivae, chemosis: A score of "1" in all animals only 1 h p.a.
Additional finding. Ocular discharge in 1/3 animals only 1 h p.a.
Other effects:
No signs of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Only slight irritations of the conjunctivae were observed at 1 and 24 h p.a. The substance is not classified as irritant.
Executive summary:

Eye irritation was investigated according to the EU- and OECD-methods. The equivalent of 0.1 mL of the test substance was instilled into the conjunctival sac of one eye of each of 3 New Zealand White rabbits. Results:

Corneae and irises: Not affected at any observation point.

Conjunctivae, redness and chemosis: slight irritations were observed at 1 and 24 h p.a., returning to normal afterwards. The substance is not classified as irritant.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

No classification is derived from the results.