Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: Not irritating to the skin.
Eye irritation: Not irritating to the eye.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin corrosion: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
April-May 2015
Reliability:
1 (reliable without restriction)
Qualifier:
according to guideline
Guideline:
OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
Deviations:
yes
Remarks:
: A standard deviation of 18.5% concerning the viability of the negative control was recorded instead of 18%.
Qualifier:
according to guideline
Guideline:
other: Test method B.40bis Council regulation n°440/2008
GLP compliance:
yes (incl. QA statement)
Vehicle:
unchanged (no vehicle)
Duration of treatment / exposure:
3 minutes and 1 hour exposure
Observation period:
Not applicable
Irritation / corrosion parameter:
% tissue viability
Value:
132.9
Remarks on result:
other: 3 minutes exposure
Irritation / corrosion parameter:
% tissue viability
Value:
92.55
Remarks on result:
other: 1 hour exposure

The mean viability of epidermis skins treated with the positivecontrol item (potassium hydroxide 8N) was 8.28% and 0.52% respectively 3 minutes and 1 hour after the application.

Interpretation of results:
other: not corrosive
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
In accordance with Regulation EC 1272/2008, the test item does not have to be classified in category 1 'Corrosive'.

Nickel 2-ethylhexanaote does not have to be classified also as 'Corrosive' according to the criteria for classification, packaging and labelling of dangerous substances in compliance with the E.E.C. Directives 67/548, 2001/59 and 99/45.
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
May - June 2015
Reliability:
1 (reliable without restriction)
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 (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
4-hours
Observation period:
1 hour and then 24, 48 and 72 hours after removal of the patch
Number of animals:
3 animals
Irritation parameter:
erythema score
Basis:
other: mean animal #1
Time point:
other: 24, 48 and 72 hours
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
other: mean animal #2
Time point:
other: 24, 48 and 72 hours
Score:
1.3
Max. score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
other: mean animal #3
Time point:
other: 24, 48 and 72 hours
Score:
1.3
Max. score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
other: mean animal #1
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
other: mean animal #2
Time point:
other: 24, 48 and 72 hours
Score:
2
Max. score:
2
Reversibility:
fully reversible within: between day 7 and day 14
Irritation parameter:
edema score
Basis:
other: mean animal #3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Other effects:
On the cutaneous structure, roughness ans loss of litheness was noted in one animal on day 7. The skin recovered a normal aspect on day 14. On the last day (day 14), dryness of the skin was noted in the two other animals.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item does not have to be classified.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
April-May 2015
Reliability:
1 (reliable without restriction)
Qualifier:
according to guideline
Guideline:
OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying Ocular Corrosives and Severe Irritants)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU method B.48 (Isolated chicken eye test method for identifying occular corrosives and severe irritants)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Vehicle:
unchanged (no vehicle)
Duration of treatment / exposure:
The test item was previously out on a gauze which was applied on the eye to cover the entire surface of the cornea. The test item was applied for 10 seconds and then rinsed from the eye with 20 mL of physiological saline at ambient temperature.
Observation period (in vivo):
Treated corneas are evaluated pretreatment and starting at 30, 75, 120, 180 and 240 minutes (+/- 5 min.) after the post-treatment rinse.
Irritation parameter:
cornea opacity score
Value:
0
Remarks on result:
other: maximal mean score = 0.0 corresponding to ICE class I
Irritation parameter:
fluorescein retention score
Value:
2.3
Remarks on result:
other: maximal mean score = 2.3 corresponding to ICE class III
Irritation parameter:
corneal swelling 
Value:
8
Remarks on result:
other: maximal mean = + 8% corresponding to ICE class II
Other effects / acceptance of results:
Corneal opacity: maximal mean score = 0.0 corresponding to ICE class I
Fluorescein retention: maximal mean score = 2.3 corresponding to ICE class III
Corneal swelling: maximal mean = + 8% corresponding to ICE class II
Combination of the 3 endpoints: 1 x III, 1 x II, 1 x I

The combination of the 3 endpoints for the positive control, sodium hydroxide, was 3 x IV. Therefore the positive control is classified as 'Corrosive/severe irritant' as expected.

The combination of the 3 endpoints for the negative control, physiological saline, was 3 x I. Therefore the negative control as 'No category' as expected.

Interpretation of results:
other: not corrosive/severe irritant
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
In accordance with Regulation EC 1272/2008, the test item does not have to be classified in category 1 'Irreversible effects on the eye'.

Nickel 2-ethylhexanaote does not have to be classified also R41 'Risk of serious damage to eyes' according to the criteria for classification, packaging and labelling of dangerous substances in compliance with the E.E.C. Directives 67/548, 2001/59 and 99/45.
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
May-June 2015
Reliability:
1 (reliable without restriction)
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
0.1 g of the test item was instilled, as supplied, into the conjunctival sac of one eye.
Observation period (in vivo):
Ocular examinations were performed on both eyes 1 hour, 24, 48 and 72 hours following treatment.
Number of animals or in vitro replicates:
3 animals
Irritation parameter:
chemosis score
Basis:
other: mean animal #1
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
other: mean animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
other: mean animal #3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
other: conjunctivae - redness
Basis:
other: mean animal #1
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
other: conjunctivae - redness
Basis:
other: mean animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: between day 1 and day 2
Irritation parameter:
other: conjunctivae - redness
Basis:
other: mean animal #3
Time point:
other: 24, 48 and 72 hours
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: between day 1 and day 2
Irritation parameter:
iris score
Basis:
other: mean animal #1
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
other: mean animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
other: mean animal #3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
other: mean animal #1
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
other: mean animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
other: mean animal #3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item does not have to be classified.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for selection of skin irritation / corrosion endpoint:
Key study

Justification for selection of eye irritation endpoint:
Key study

Justification for classification or non-classification

Skin corrosion:

Reference Colas (2015a) is considered as the key study for skin corrosion and will be used for classification. The overall irritation results are as follows:

- relative viability 3 minutes after treatment: 132.90%

- relative viability 1 hour after treatment: 92.55%.

The classification criteria according to regulation EC 1272/2008 as corrosive to the skin are not met since the relative viability after 3 minutes and 1 hour was above 50% and 15% respectively, hence no classification is required.

Skin irritation:

Reference Colas (2015b) is considered as the key study for skin irritation and will be used for classification.

According to the Acute dermal irritation test, the overall irritation results 24 - 48 and 72 hours after application per animal are as follows:

- erythema and eschar: 1.0 - 1.3 - 1.3;

- oedema: 0.0 - 2.0 - 0.0.

Results do not meet the criteria for classification (mean value ≥ 2.0 for one endpoint for all animals or for the 2 endpoints in at least 2 animals) according to regulation (EC) 1272/2008 as skin irritant, hence no classification required.

Eye irritation:

The references Colas (2015) are considered as the key studies for severe eye irritation and will be used for classification

According to the Isolated chicken eye test method, the ocular reactions observed were:

- maximal mean score of corneal opacity: 0.0 corresponding to ICE class I;

- maximal mean score of fluorescein retention: 2.3, corresponding to ICE class III;

- maximal mean corneal swelling: + 8%, corresponding to ICE class II.

The combination of the three endpoints does not meet classification criteria according to regulation EC 1272/2008 as severe eye irritation. No classification is required.

According to the Acute eye irritation test, the overall irritation results 24 - 48 and 72 hours after application per animal are as follows:

- corneal opacity = 0.0 for all three animals,

- iris lesion = 0.0 for all three animals,

- conjunctivae redness = 0.0 - 0.3 - 0.3,

- conjunctival oedema (chemosis) = 0.0 for all three animals.

The classification criteria according to regulation EC 1272/2008 as irritating to the eyes are not met, since the value for conjunctival redness was below the threshold of ≥ 2 as well as the effect was fully reversible. Hence, no classification is required.

Respiratory irritation:

The available data do not allow any conclusion on respiratory irritation.