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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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/ corrosion: Key study: Test method according to OECD guideline 404 under GLP conditions, Although there were some effects like yellowdish discoloration in 1/3 animals on day 3 and 4, changes were fully reversible within 6 days.
Eye irritation: Key study: Test method according to OECD guideline 405 under GLP conditions. Brownish or withish areas on the conjunctivae were noted in all the animals, changes were not fully reversible within 22 days.

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: Test method according to OECD 404. GLP study.
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
other: 92/69/EWG.
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
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: 500 mg.
Duration of treatment / exposure:
4 hours.
Observation period:
72 hours.
Number of animals:
3
Details on study design:
SCORING SYSTEM: Scoring system according to OECD guideline 404, EU method B.4.
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h.
Score:
1
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h.
Score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h.
Score:
0
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: overall at 24, 48 and 72 h.
Score:
0.33
Max. score:
1
Reversibility:
other: Max. duration: 5 d.; Max value at end of observation period : 0 (related to all animals)
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h.
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h.
Score:
0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: overall at 24, 48 and 72 h.
Score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: overall at 24, 48 and 72 h.
Score:
0
Max. score:
0
Reversibility:
other: Max. duration: 0 d.; Max value at end of observation period : 0 (related to all animals)
Irritant / corrosive response data:
Reversibility of a y observed effect: Changes fully reversible within 6 days.
Other effects:
After 4 hours' exposure to light (three animals), a yellowish discoloration of the treated are of skin was observed in 1/2 of the animals on day 3 and 4.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance showed no potential of skin irritation/corrosion.
Executive summary:

A skin irritation/ corrosion test was performed according to OECD guideline 404, EU method B.4. and 92/69/EWG. Three New Zealand white rabbits were exposed in semiocclusive conditions to 500 mg of the test substance for 4 hours. A yellowish discoloration of the treated area of skin was observed in 1/3 animals on days 3 and 4. Changes were fully reversible within 6 days.

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: Test method according to OECD 405. GLP study.
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
other: 92/69/EWWG.
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Controls:
other: Untreated eye serves as control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 100 mg.
Duration of treatment / exposure:
Single application.
Observation period (in vivo):
22 days.
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM: Scoring system according to OECD 405 and EU method B.5.
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h.
Score:
2.3
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h.
Score:
3
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h.
Score:
2.7
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
mean
Time point:
other: overall at 24, 48 and 72 h.
Score:
2.67
Max. score:
3
Reversibility:
other: Max duration: h; Max value at the end of observation period: 2 (related to all animals).
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h.
Score:
1.7
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h.
Score:
3
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h.
Score:
3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: overall at 24, 48 and 72 h.
Score:
0.9
Max. score:
3
Reversibility:
other: Max duration: h; Max value at the end of observation period: 3 (related to all animals).
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h.
Score:
0.7
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h.
Score:
1.3
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h.
Score:
2
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: overall at 24, 48 and 72h.
Score:
1.33
Max. score:
2
Reversibility:
other: Max duration: h; Max value at the end of observation period: 1 (related to all animals).
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h.
Score:
0.7
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h.
Score:
1
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h.
Score:
1
Irritation parameter:
iris score
Basis:
mean
Time point:
other: overall at 24, 48 and 72 h.
Score:
0.9
Max. score:
1
Reversibility:
other: Max duration: h; Max value at the end of observation period: 1 (related to all animals).
Irritant / corrosive response data:
Reversibility of any observed effect: Changes were not fully reversible within 22 days.
Other effects:
Brownish or whitish areas on the conjunctivae were noted in all the animals. Neovascularisation and alopecia around the eye, continuing at the end of the observation period, were observed in 1/3 animals.
Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance resulted irritating to the eye of the rabbits. Changes were not fully reversible within 22 days.
Executive summary:

A study for eye irritation/ corrosion was performed according to OECD 405, EU method B.5 and 92/69/EWG. Three white New Zealand rabbits were instilled 100 mg of the test substance into one eye, the untreated served as control. The following irritation parameters were recorded at 24, 48 and 72 according to OECD 404 scoring system: Conjunctivae score (redness), chemosis score, cornea score and iris score. Adverse effects were seen for all irritation parameters. Changes were not fully reversible within 22 days. The substance can be classified as ocular irritant.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Eye irritation: Key study: A study for eye irritation/ corrosion was performed according to OECD 405, EU method B.5 and 92/69/EWG. Three white New Zealand rabbits were instilled 100 mg of the test substance into one eye, the untreated served as control. The following irritation parameters were recorded at 24, 48 and 72 according to OECD 404 scoring system: Conjunctivae score (redness), chemosis score, cornea score and iris score. Adverse effects were seen for all irritation parameters. Changes were not fully reversible within 22 days.

Skin irritation/ corrosion: Key study:

A skin irritation/ corrosion test was performed according to OECD guideline 404, EU method B.4. and 92/69/EWG. Three New Zealand white rabbits were exposed in semiocclusive conditions to 500 mg of the test substance for 4 hours. A yellowish discoloration of the treated area of skin was observed in 1/3 animals on days 3 and 4. Changes were fully reversible within 6 days.


Justification for selection of skin irritation / corrosion endpoint:
Only one study available.

Justification for selection of eye irritation endpoint:
Only one study available.

Effects on eye irritation: corrosive

Justification for classification or non-classification

The minor effects and the reversibility seen in the skin irritation study are not sufficient to classify the substance for skin irritation/ corrosion.

Given that changes are not fully reversible within 22 days of observation at the eye irritation study, the test substance classify for irreversible effects on the eye. (Category 1)