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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 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
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
December 2015 - February 2016
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:
other: shorn
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 g
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:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritant / corrosive response data:
No cutaneous reactions (erythema and oedema) were observed whatever the examination tone (1, 24, 48 and 72 hours).
Interpretation of results:
not irritating
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
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
December 2015 - March 2016
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:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: between days 1 and 7
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.7
Max. score:
1
Reversibility:
fully reversible within: between days 1 and 7
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.7
Max. score:
2
Reversibility:
fully reversible within: between days 2 and 7
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.7
Max. score:
2
Reversibility:
fully reversible within: between days 2 and 7
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: between days 2 and 7
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: on day 2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: on day 3
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Interpretation of results:
not irritating
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 classification or non-classification

Skin corrosion:

Reference Colas (2016) 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: 106.58%

- relative viability 1 hour after treatment: 106.61%.

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 Richeux (2016) 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: 0.0 – 0.0 – 0.0;

- oedema: 0.0 – 0.0 – 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 Genuer (2016) and Richeux (2016) 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: 0.5 corresponding to ICE class I;

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

- maximal mean corneal swelling: + 2%, corresponding to ICE class I.

In accordance with regulation EC 1272/2008, the results obtained under these experimental conditions do not enable to classify the test item. Molybdic acid was not predicted as causing serious eye damage with the Isolated chicken eye test method.

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 = 1.0 – 0.0 – 0.0,

- iris lesion = 0.3 - 0.0 – 0.0,

- conjunctivae redness = 1.7 - 0.7 – 1.0,

- conjunctival oedema (chemosis) = 2.0 – 0.0 – 0.7.

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.