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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

not irritant to skin (500 mg) nor to eye (100 mg);
Respiratory irritation: waived = hazard unkown (no further information required) - qualitative RC (anti-dust protection)

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:
from 2007-12-20 till 2007-12-22
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline-conform study under GLP without deviations.
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
2004/73/EG, B.4
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
rbt, New Zealand White HsdIf:HZW
Type of coverage:
semiocclusive
Preparation of test site:
other: clipping
Vehicle:
other: aqua ad inject
Controls:
other: The untreated other side served as control.
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 h
Observation period:
Animals were examined for signs of erythema and oedema at 1, 24, 48 and 72 hours after patch removal.
Number of animals:
3
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 - 72 hours
Score:
0
Max. score:
0
Reversibility:
other: no effect
Remarks on result:
other: Max. duration: d; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 - 72 hours
Score:
0
Max. score:
0
Reversibility:
other: no effect
Remarks on result:
other: Max. duration: d; Max. value at end of observation period: 0 (related to all animals)
Irritant / corrosive response data:
none
Other effects:
No effects observed.

   
   
Interpretation of results:
other: not classified
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Considering the reported data of this irritation study it can be stated that the test item showed no irritant/corrosive effects.
According to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in Commission Directive 93/21 EEC) the test item does not have to be classified and has no obligatory labelling requirement for skin irritation.
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:
from 2007-11-21 till 2008-01-13
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline-conform study under GLP without deviations.
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
2004/73/EG, B.5
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
New Zealand White Rabbits HsdIf:NZW
Vehicle:
unchanged (no vehicle)
Controls:
other: The untreated contralateral eye served as control
Number of animals or in vitro replicates:
3
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Time point:
other: overall at 24, 48 and 72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Time point:
other: overall at 24, 48 and 72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Time point:
other: overall at 24, 48 and 72 h
Score:
1.33
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
mean
Time point:
other: 24 - 72 hours
Score:
0.33 - <= 1.33
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
other: Max. duration: 72 h; Max. value at end of observation period: 1 (related to all animals)
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: overall at 24, 48 and 72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: overall at 24, 48 and 72 h
Score:
0.66
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 - 72 hours
Score:
0.33 - <= 0.66
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
other: Max. duration: 24 h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 - 72 hours
Score:
0
Max. score:
0
Reversibility:
other: no effect
Remarks on result:
other: Max. duration: h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 - 72 hours
Score:
0
Max. score:
0
Reversibility:
other: no effect
Remarks on result:
other: Max. duration: h; Max. value at end of observation period: 0 (related to all animals)
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 4 days
Interpretation of results:
other: not classified
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Considering the reported data of this irritation study it can be stated that the test item
produced slightly to obviously irritating effects.
According to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in Commission Directive 93/21 EEC) the test item does not have to be classified and has no obligatory labelling requirement for eye irritation.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

An acute Dermal Irritation/Corrosion test with the test substance was performed according to OECD 404,Directive 2004/73/EC B.4 with rabbits.

The test item was held in contact with the skin throughout a 4-hour period. A dose of 0.5 g of the test item was applied to each test site. Animals were examined for signs of erythema and oedema at 1, 24, 48 and 72 hours after patch removal. For the determination of classification-relevant values, the animals were examined for signs of erythema and oedema at 24, 48 and 72 hours after patch removal.

The test item showed neither irritant nor corrosive effects on the intact skin of 3 rabbits (strain NZW) after a contact time of 4 hours. There were no significant body weight changes during the contact and observation period. The Primary Irritation Index (PII) was 0.

An acute Eye Irritation/Corrosion test with the test substance was performed according to OECD 405,2004/73/EG, B.5 with rabbits.

In this eye irritation study the test item was applied to the lower conjunctival sac of one eye of 3 female NZW - rabbits (HsdIf:NZW) at a dose of 0.1 g per application site. The untreated other eye served as control. Observations were calculated and compared to the control eyes, 24 h, 48 h, 72 h post-dose. The observation period was prolonged until no signs of irritation were recorded (animal no. 1 and 2: 72 hours, animal no. 3: 96 hours post instillation). Animal no. 1 showed redness and chemosis grade 2 and discharge grade 1 of the conjunctivae 1 h after instillation. 24 h post instillation redness grade 2 and chemosis grade 1 of the conjunctivae were recorded. 24 h post instillation no discharge was recorded. 48 h post instillation redness grade 1 was recorded.

No symptoms were observed 72 hours post instillation. Animal no. 2 showed redness and discharge grade 1, chemosis grade 2 of the conjunctivae 1 h after instillation. After 24 h redness grade 1 of the conjunctivae, but no signs of chemosis and discharge were recorded.

No symptoms were observed 48 hours post instillation. Animal no. 3 showed redness, chemosis and discharge grade 2 of the conjunctivae 1 h and 24 h after instillation. 48 h after instillation redness and discharge grade 1 of the conjunctivae were recorded. 72 h after instillation redness grade 1 of the conjunctivae was recorded; no signs of dicharge were recorded.

No symptoms were observed 96 hours post instillation. No other toxic effects were observed. The eyes were not rinsed. Throughout the observation period no weight loss was recorded in the test animals. The calculated mean scores did not exceed the limit values according to Directive 93/21 EEC in any case.


Justification for selection of skin irritation / corrosion endpoint:
only existing study is sufficient

Justification for selection of eye irritation endpoint:
only existing study is sufficient

Justification for classification or non-classification

According to the GHS criteria, listed in Annex I, the substance does not have to be classified as a hazardous substance regarding irritation/corrosion.