Registration Dossier

Administrative data

Description of key information

Substance is classified as corrosive to skin and 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
Study period:
1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 3.03-3.16 kg
- Housing: Individual suspended metal cages
- Diet (e.g. ad libitum): STANRAB SQC Rabbit diet, Special dies Ltd, Witham, Essex, UK, ad libitum
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: minimum 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-21
- Humidity (%): 44-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): 50 % w/w

Duration of treatment / exposure:
3 min, 1 hour, and 4 hours, respectively
Observation period:
14 days after exposure
Number of animals:
3
Irritation parameter:
erythema score
Basis:
animal: 29 Male
Time point:
24 h
Score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal: 29 Male
Time point:
48 h
Score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal: 29 Male
Time point:
72 h
Score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal: 174 Male
Time point:
24 h
Score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal: 174 Male
Time point:
48 h
Score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal: 174 Male
Time point:
72 h
Score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal: 175 Female
Time point:
24 h
Score:
4
Reversibility:
not reversible
Irritation parameter:
erythema score
Basis:
animal: 175 Female
Time point:
48 h
Reversibility:
not reversible
Remarks on result:
other: Adverse reactions prevented accurate evaluation of erythema
Irritation parameter:
erythema score
Basis:
animal: 175 Female
Time point:
72 h
Reversibility:
not reversible
Remarks on result:
other: Adverse reactions prevented accurate evaluation of erythema
Irritation parameter:
edema score
Basis:
animal: 29 Male
Time point:
24 h
Score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal: 29 Male
Time point:
48 h
Score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal: 29 Male
Time point:
72 h
Score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal: 174 Male
Time point:
24 h
Score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal: 174 Male
Time point:
48 h
Score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal: 174 Male
Time point:
72 h
Score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal: 175 Female
Time point:
24 h
Score:
3
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal: 175 Female
Time point:
48 h
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: Adverse reactions prevented accurate evaluation of edema
Irritation parameter:
edema score
Basis:
animal: 175 Female
Time point:
72 h
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: Adverse reactions prevented accurate evaluation of edema
Irritation parameter:
erythema score
Basis:
animal: 29 Male
Time point:
other: 24 hours after 3 min exposure
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal: 29 Male
Time point:
other: 24 hours after 1 hour exposure
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 14 days
Irritant / corrosive response data:
Discoloration of skin, necrosis and scar tissue was observed during the study.
Interpretation of results:
Category 1C (corrosive) based on GHS criteria
Conclusions:
Substance is corrosive to rabbit skin.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vitro / ex 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)
Endpoint conclusion
Endpoint conclusion:
no study available

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for selection of skin irritation / corrosion endpoint:
Only data available. Reliability 1 due to GLP study done according to OECD guideline.
Result is as expected due to the content of NaOH in the test solution (due to the production method)

Effects on skin irritation/corrosion: corrosive
Effects on eye irritation: corrosive

Justification for classification or non-classification

Substance has a high pH of 12 -13 and a content of sodium hydroxide, which all warrants for the classification as corrosive to skin and eyes.