Registration Dossier

Administrative data

Description of key information

OECD guideline, GLP-compliant studies were conducted in vivo to assess skin and eye irritation. The results of these studies indicated that the test substance was not irritating to skin or eyes.

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:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
Updated version, adopted on 17 July 1992
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
Dated 31 July 1992
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: young adult
- Weight at study initiation: 2240-2530g
- Housing: individually housed in stainless cages with perforated floor
- Diet (e.g. ad libitum): standard laboratory rabbit diet ad libitum
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: 13 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/-3°C
- Humidity (%): 60-70%
- Air changes (per hr): ca. 10 air changes/hour
- Photoperiod (hrs dark / hrs light):12 hours dark, 12 hours light

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.25 mL
Duration of treatment / exposure:
4 hours
Observation period:
Up to 72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: back and flank of each animal
- % coverage: not reported
- Type of wrap if used: self adhesive gauze

REMOVAL OF TEST SUBSTANCE
- Washing (if done): cleaned with moistened tissue
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
(indicate if minutes, hours or days) 1h, 24h, 48h, 72h.

SCORING SYSTEM:
- Method of calculation: Draize et al (1944)
Irritation parameter:
overall irritation score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects seen
Remarks on result:
no indication of irritation
Irritation parameter:
overall irritation score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects seen
Remarks on result:
no indication of irritation
Irritation parameter:
overall irritation score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects seen
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Time point:
24/48/72 h
Score:
0
Reversibility:
other:
Remarks:
no effects seen
Irritation parameter:
edema score
Time point:
24/48/72 h
Score:
0
Reversibility:
other:
Remarks:
no effects
Irritant / corrosive response data:
No oedema or erythema seen on any of the animals at the observation time points.
Other effects:
None.
Interpretation of results:
GHS criteria not met
Conclusions:
No irritation was seen throughout the duration of the study where the test substance had been applied 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
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:
second updated version, adopted in 1987
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
31st July 1992
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: young adult
- Weight at study initiation: 2220-2410g
- Housing: individually housed in stainless steel cages with perforated floor
- Diet (e.g. ad libitum): standard laboratory rabbit diet ad libitum
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: 13 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 60-70%
- Air changes (per hr): ca. 10
- Photoperiod (hrs dark / hrs light): 12 hours dark/ 12 hours light

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.063g (equivalent to 0.1mL)
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): none

Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effect seen
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects seen
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects seen
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects seen
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects seen
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects seen
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.7
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.7
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.7
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Remarks:
Oedema
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Remarks:
Oedema
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 3 days
Other effects:
One hour after instillation of the test substance, discharge
was noted as well as conjunctival redness (grade 2) and
swelling (grade 1).
Interpretation of results:
GHS criteria not met
Conclusions:
This test substance was determined to be not irritating to eyes.
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

In both the in vivo skin and eye irritation studies, the irritation scores for the relevant assessment endpoints were lower than the criteria set for classification under the CLP regulation (1272/2008EC, as amended) and therefore no classification is warranted for skin or eye irritation.