Registration Dossier

Administrative data

Description of key information

Six male rabbits were treated with the substance under occlusion during 24 hours (Fraunhofer 1980). Observations at 24 and 72 hours and at 8 days showed full destruction of the skin with penetration in the subcutaneous tissue. The substance is corrosive to the skin.

The substance as tested is a severe eye irritant (Fraunhofer 1980)

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:
1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
according to
Guideline:
other: Code of Federal Regulations, Title 16 section 1500.51
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: W Ostrop/Meerbusch
- Age at study initiation: no data
- Weight at study initiation: mean 2.6 kg
- Housing: individually (restrained)
- Diet: mümmel z, SNIFF Soest ad libitum
- Water: ad libitum
- Acclimation period: 7-14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-19 °C
- Humidity (%): 40%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light):12/12
Type of coverage:
occlusive
Preparation of test site:
clipped
Remarks:
test was done on intact and abraded skin
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
500 ug
Duration of treatment / exposure:
24 hours
Observation period:
at 24 (at removal of the dressing), 48 (not reported) and 72 hours and after 8 days
Number of animals:
6 males
Details on study design:
TEST SITE
- Area of exposure: 5x5 cm
- Type of wrap if used: occlusive, chirurgical gaze with PVC cover

REMOVAL OF TEST SUBSTANCE
- Washing (if done): none

OBSERVATION TIME POINTS
(indicate if minutes, hours or days) at 24 (at removal of the dressing), 48 (not reported) and 72 hours and after 8 days

SCORING SYSTEM:
- Method of calculation: Draize
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48 h
Remarks on result:
not determinable
Remarks:
staining of the skin at 24 and 72 hours and after 8 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Remarks:
at 24 and 72 h
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48 h
Score:
3.5
Max. score:
4
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Remarks:
at 24 and 72 h
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Remarks:
at 24 and 72 h
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48 h
Score:
4
Max. score:
4
Reversibility:
other:
Remarks on result:
positive indication of irritation
Remarks:
at 24 and 72 h
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Remarks:
at 24 and 72 h
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Remarks:
at 24 and 72 h
Irritant / corrosive response data:
full destruction of the dermis was observed with penetration in the subcutaneous tissue. Therefore the substance is considered corrosive to the skin
Interpretation of results:
Category 1 (corrosive) based on GHS criteria
Conclusions:
Under the conditions of the test the substance is corrosive to the skin
Executive summary:

Six male rabbits were treated with the substance under occlusion during 24 hours. Observations at 24 and 72 hours and at 8 days showed full destruction of the skin with penetration in the subcutaneous tissue. The substance is corrosive to the skin.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Qualifier:
according to
Guideline:
other: Code of Federal Regulations, title 16, section 1500,42
Principles of method if other than guideline:
No details on the application were included the report contains a table with the results
GLP compliance:
no
Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
no data
Vehicle:
not specified
Controls:
not required
Amount / concentration applied:
no data
Duration of treatment / exposure:
NA
Observation period (in vivo):
after 24, 48 and 72 hours and on day 8
Number of animals or in vitro replicates:
6
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3.3
Max. score:
3
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3.3
Max. score:
4
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
3.3
Max. score:
4
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24/48/72 h
Score:
3.3
Max. score:
4
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Irritation parameter:
other: discharge
Basis:
mean
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
not reversible
Irritant / corrosive response data:
Scoring of the conjuctivae was not possible due to staining by the substance
Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
The substance as tested is a severe eye irritant
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Based on the available data the substance needs to be classified as corrosive (category 1) according to REGULATION (EC) No 1272/2008.