Registration Dossier

Administrative data

Description of key information

In an GLP-compliant, in vivo skin irritation study conducted in accordance with OECD guideline, corrosive effects were seen in one animal in this study. The effects were irreversible after 14 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
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
GLP compliance:
no
Species:
rabbit
Strain:
other: Japanese White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Kitayama LABES Co., Ltd
- Age at study initiation: 11 weeks old
- Weight at study initiation: 2.51 - 2.64 kg
- Housing: Hanging type aluminium cages (32W x 48D x 33H cm, stainless steel mesh flooring)
- Diet (e.g. ad libitum): Pellet diet, ad libitum
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: 1 day after 7 day quarantine period

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.9 - 24.1°C
- Humidity (%): 45.1 - 63.0 %
- Air changes (per hr): 6 - 20
- Photoperiod (hrs dark / hrs light): 12h dark, 12h light
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
other: olive oil
Controls:
yes, concurrent vehicle
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g test substance

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.15 mL
- Lot/batch no. (if required): 70910
Duration of treatment / exposure:
4 hours
Observation period:
14 days
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: dorsal area of the trunk
- coverage: approx 6cm2
- Type of wrap if used: semi-occlusive elastic bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 hours

OBSERVATION TIME POINTS
1, 24, 48, 72 hours then 7, 10, 14 days

SCORING SYSTEM:
- Method of calculation: following the OECD guideline
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
not reversible
Remarks:
eschar formation was observed after 7 days and did not reverse by the end of the 14 day observation period
Remarks on result:
probability of severe irritation
Remarks:
Max score achieved on Day 7, 10 and 14 observations
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other:
Remarks:
no effect
Other effects:
- Other adverse local effects: Irreversible effects to the skin was observed in one animal during the study

No irritation was seen in the control animals (treated with olive oil) all scores zero.

Interpretation of results:
Category 1 (corrosive) based on GHS criteria
Conclusions:
The substance is concluded to be corrosive/severly irritating to skin and therefore a classification of Skin Corrosion Category 1 is applied.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance is classified as skin corrosion, leading to classification as serious eye damage (Category 1)
Reason / purpose for cross-reference:
data waiving: supporting information
Reason / purpose for cross-reference:
data waiving: supporting information
Endpoint conclusion
Endpoint conclusion:
no study available

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Based on the result of the in vivo skin irritation test where one animal showed evidence of irreversible corrosive effects and the local corrosive effects seen in the acute dermal study, this substance is classified as Skin Corrosion 1 (H314) in accordance with the CLP Regulation (EC 1272/2008, as amended). Data are not available to subcategorise the classification of this substance for this endpoint. Although no study is available to assess eye irritation; the substance is classified as corrosive to skin and therefore the classification of Eye damage 1 (H318) is automatically assigned in accordance with the CLP Regulation (EC 1272/2008).