Registration Dossier

Administrative data

Description of key information

skin irritation, rabbit: not irritating
eye irritation, rabbit: slightly irritating
With regard to local effects in the respiratory tract the substance is classified for repeated toxicity with STOT RE 1 (see chapter 'Repeated Dose Toxicity’).

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- SPF Quality
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: at least 6 weeks old; weights between 1.0 and 3.5 kg
- sex: males
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
other: solid was moistened with 0.3 mL water
Controls:
other: surrounding untreated skin area of test animals served as control
Amount / concentration applied:
Amount: 0.5 g
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48, and 72 hours after application
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: approx. 6 cm²
- Type of wrap if used: non irritating tape

REMOVAL OF TEST SUBSTANCE
- 4 hours after application the dressing was removed and the skin cleaned of residual test substance using water

SCORING SYSTEM: Draize
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Other effects:
There were no systemic intolerance reactions.
Interpretation of results:
GHS criteria not met
Conclusions:




Classification: not irritating
Executive summary:

In a study performed according to OECD 404 the test item was shown to be not irritating to rabbit's skin. No systemic intolerance reactions were observed.

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Sex: female
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: at least 6 weeks old; body weights were between 1.0 and 3.5 kg
Vehicle:
unchanged (no vehicle)
Controls:
other: one untreated eye of test animals served as control
Amount / concentration applied:
The test item was gound to a powder using a mortar and pestle prior to weighing.
Amount: about 60.9 mg (according to about 0.1 mL)

Duration of treatment / exposure:
single treatment; the lid was held together for about one second after instillation
Observation period (in vivo):
24 hours after administration the eyes were treated with fluorescein and examined
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: none

SCORING SYSTEM: Draize
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 h
Remarks:
(score 1 at 24 h)
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 h
Remarks:
(score 1 at 24 h)
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 h
Remarks:
(score 1 at 24 h)
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks:
(score 1 at 24 h)
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Other effects:
There were no systemic intolerance reactions.
Interpretation of results:
GHS criteria not met
Conclusions:



Classification: not irritating
Executive summary:

In a study performed according to OECD 405 the solid test item led to slight effects to the eyes of rabbits (redness grade 1 in all 3 animals and chemosis grade 1 in 1 animal) 24 hours after treatment. The effects disappeared 24 hours later. 1 hour after instillation remnants of the test substance and eye effects were observed.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

In a study performed according to OECD 404 the test item was shown to be not irritating to rabbit's skin. No systemic intolerance reactions were observed.

In a study performed according to OECD 405 the solid test item led to slight effects to the eyes of rabbits (redness grade 1 in all 3 animals and chemosis grade 1 in 1 animal) 24 hours after treatment. The effects disappeared 24 hours later. 1 hour after instillation remnants of the test substance and eye effects were observed.

With regard to local effects in the respiratory tract the substance is classified for repeated toxicity with STOT RE 1 (see chapter 'Repeated Dose Toxicity’).

Justification for classification or non-classification

The substance is not irritating to skin (Notox, 2001b) and only slightly irritating to eyes (Notox, 2001c), results that do not meet criteria according to EC Regulation 1272/2008 to be classified.

With regard to local effects in the respiratory tract the substance is classified for repeated toxicity with STOT RE 1 (see chapter 'Repeated Dose Toxicity').