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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Study period:
2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
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:
guinea pig
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Conditions
Standard Laboratory Conditions.
Air- conditioned with ranges for room temperature 17-23°C, relative humidity 30-70% and apporximately 10-15 air changes per hour. Room temperature and humidity were monitored continuously and values outside of these ranges may have occasionally occured, usually following room cleaning. These transient variations are considered not to have any influence on the study. The animals were provided with an automatically controlled light cycle of 12 hours light and 12 hours dark. Music was played during the daytime light period.

Accomodation
Individually in stainless steel caged equipeed with feed hoppers and drinking water bowls.
Diet
Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum
Water
Community tap water from Fullinsdorf ad libitum

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
4h
Observation period:
1, 24,48 and 72 hours after exposure
Number of animals:
3
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal number 61
Time point:
24/48/72 h
Score:
0.33
Max. score:
0.33
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal number 62
Time point:
24/48/72 h
Score:
0.33
Max. score:
0.33
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal number 63
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal number 61
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal number 62
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal number 63
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation

VIABILITY /MORTALITY/CLINICAL SIGNS:

No clinicals signs of systemi toxicity were observed in the animals during the study and no mortality occured.

IRRITATION

The mean score was calculated across 3 scoring times (24,48 and 72 hours after patch removal) for each animal for erythema/eschar grades and for oedema grades, separately.

No abnormal findings were observed on the treated skin of any animal 48 hours after treatment.

A very slight to well-defined erythema was noted in all animals at the 1-hour reading. The erythema persisted as slight in two animals untile the 24-hour reading- At the 1-hour reading all the animals showed a very slight edema which did no persist. No staining produced by the test item of the treated skin was observed.

CORROSION

Neither alterations of the treated skin were observed nor were corrosive effects evident on the skin.

Interpretation of results:
GHS criteria not met
Conclusions:
The substance is considered to be "not irritating" to skin
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:
2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
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
Species:
rabbit
Strain:
New Zealand White
Amount / concentration applied:
0.1g
Observation period (in vivo):
1,24,48, 72 hours and 7 days after instillation
Number of animals or in vitro replicates:
3
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal number 64
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal number 65
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal number 66
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal number 64
Time point:
7 d
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal number 65
Time point:
7 d
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal number 66
Time point:
7 d
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal number 64
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal number 65
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal number 66
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal number 64
Time point:
7 d
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal number 65
Time point:
7 d
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal number 66
Time point:
7 d
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal number 64
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal number 65
Time point:
24/48/72 h
Score:
0.67
Max. score:
1
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal number 66
Time point:
24/48/72 h
Score:
1
Max. score:
1
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal number 64
Time point:
7 d
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal number 65
Time point:
7 d
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal number 66
Time point:
7 d
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal number 64
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal number 65
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal number 66
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal number 64
Time point:
7 d
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal number 5
Time point:
7 d
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal number 66
Time point:
7 d
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation

VIABILITY /MORTALITY/CLINICAL SIGNS:

No clinicals signs of systemi toxicity were observed in the animals during the study and no mortality occured.

IRRITATION / CORROSION

The mean score was calculated across 3 scoring time (24, 48 and 72 hours after instillation) for each animal for corneal opacity, iris, redness and chemosis of the conjunctivae, separately. The individual mean scores for corneal opacity and iris were 0.00 for all three animals. The individual mean scores for the conjunctivae were 0.33, 0.67 and 1.00 for reddening and 0.00 for chemosis for each of the three animal.

No abnormal findings were observed in the cornea or iris of any animal at any of the measurement intervals.

A slight modeate reddening of the conjunctivae was noted in all animals 1 h after instillation and persisted up to the 24 - 48- or 72- hour reading in the three animals, respectivaly. A slight to obvius swelling with partial eversion of lids was observed in all treated animals at the 1 -hour observation. Additionally, all animals expressed a slight to moderate reddening of the sclerae 1 hour after treatment which persisted as slight in one animale at the 24 hours. Furthemore, slifght to moderate ocular discharge was noted in the three animals at the 1 hour evaluation and persisted as slight in one animal at the 24 hours.

No abnormal findings were observed in the treated eye of any animale 7 day after treatmente, the end of the observation period fo all animals.

Interpretation of results:
GHS criteria not met
Conclusions:
The substance is considered to be "not irritating" to eye
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Justification for classification or non-classification