Registration Dossier

Diss Factsheets

Administrative data

Description of key information

In an in vivo eye irritation study the test item was shown to be non-irritant to the skin.


In an in vivo eye irritation study the test item produced slightly irritating effects, which were fully reversible within 2 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
Study period:
22 Feb 2007 (date of Project Protocol) - 11 April 2007 (date of Report)
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted 24 April, 2002
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
Storage conditions: at room temperature
Species:
rabbit
Strain:
New Zealand White
Remarks:
Hsdlf:NZW
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann GmbH, D-33178 Borchen
- Weight at study initiation: Animal 1: 2,9 kg; Animal 2: 2.3 kg; Animal 3: 3.0 kg
- Housing: Semi-barrier in an air conditioned room, ABS - plastic rabbit cages, floor 4200 cm²
- Diet: Free access to Altromin 2123 maintenance diet for rabbits, rich in crude fibre, totally pathogen free (TPF)
- Water: Free access to tap water (drinking water, municipal residue control, microbiol. controlled periodically)
- Acclimation period: adequate acclimatization period

ENVIRONMENTAL CONDITIONS
- Temperature: 18 ± 3 °C
- rel. Humidity: 55 ± 10%
- Air changes: at least 10x / hour
- Photoperiod (hrs dark / hrs light): artificial light: 12 h light, 12 h dark
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: Test item was applied to a small area of skin on one side of the dorsal area, the untreated other side served as control.
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
4 h
Observation period:
72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: Test item was applied to a small area (approx. 6 cm²) of skin on one side of the dorsal area
- Type of wrap if used: covered with a gauze patch, which was held in place with non-irritating tape.

OBSERVATION TIME POINTS
1, 24, 48 and 72 hours after patch removal

SCORING SYSTEM:
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. Dermal irritation was scored and recorded according to grades of the classification system below:

Erythema and Eschar Formation:
No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beef-redness) to eschar
formation preventing grading of erythema 4

Oedema formation:
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well defined by definite raising) 2
Moderate oedema (raised approx. 1 mm) 3
Severe oedema (raised more than 1 mm and extending
beyond exposure area) 4
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
The test item showed neither irritant nor corrosive effects on the intact skin of the three rabbits.
Other effects:
There were no significant body weight changes during the contact and observation period.

Body Weight

 Animal No. Start of Study (Weight kg)  End of Study (Weight kg) 
 1  2.9  3.0
 2  2.3  2.4
 3  3.0  3.1
Interpretation of results:
GHS criteria not met
Conclusions:
Based on the results of an in vivo skin irritation test performed according to OECD/EC guidelines and GLP principles, the substance was concluded to be non-irritant to the 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:
22 Feb 2007 (Date of Project Protocol) - 19 Apr 2007 (Date of Report)
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted 24 April 2002
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
Storage conditions: at room temperature
Species:
rabbit
Strain:
New Zealand White
Remarks:
Hsdlf:NZW
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann GmbH, D-33178 Borchen
- Weight at study initiation: Animal 1: 4.0 kg; Animal 2: 2.8 kg; Animal 3: 2.7 Kg
- Housing: ABS - plastic rabbit cages, floor 4200 cm²
- Diet: free access to Altromin 2123 maintenance diet for rabbits, rich in crude fibre (TPF)
- Water: free access to tap water
- Acclimation period: adequate acclimatization period

ENVIRONMENTAL CONDITIONS
- Temperature: 18 ±3°C
- Humidity: 55±10%
- Air changes: at least 10x / hour
- Photoperiod (hrs dark / hrs light): 12 / 12
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated contralateral eye severed as control
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
Single instillation
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
3
Details on study design:
The animals were observed for 72 hours after dosing.
The eyes were examined for signs of irritation throughout the observation period. Eye irritation was scored and recorded.
For calculation only the 24, 48 and 72 hour readings were used.
72 hours after administration the treated eyes were examined with the aid of a fluorescein solution.
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h post instillation
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
mean
Time point:
24/48/72 h
Score:
0.11
Max. score:
3
Remarks on result:
other: Max. duration: 24 h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Score:
0
Max. score:
4
Remarks on result:
other: Max. duration: h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
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
Remarks:
(mean score 1)
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
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 2 days.
Other effects:
No toxic effect was observed

Body Weight              

 Animal No.  Start of Study (Weight kg)  End of Study (Weight kg)
 1  4.0  4.0
 2  2.8  2.9
 3  2.7  2.8
Interpretation of results:
GHS criteria not met
Conclusions:
In an in vivo eye irritation test, performed according to OECD/EC guidelines and GLP principles, the test item produced slightly irritating effects, which were reversible within 48 hours.
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

Based on the available data, the test substance does not require classification for skin or eye irritation according to Regulation (EC) No 1272/2008.