Registration Dossier

Administrative data

Description of key information

The test substance was irritating to the skin of rabbits in a study performed according to the guidelines (Hüls, 1989).

No signs of irritation were observed when the test substance was applied to the rabbit's eye (Hüls 1989)

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:
01/03 1989 to 15/03 1989
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: conform the guideline, non-GLP
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no
Species:
rabbit
Strain:
other: white russian
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Dr. Karl Tomae GmbH Biberach
- Sex: male
- Weight at study initiation: 2.2-2.4 kg
- Housing: individual
- Diet : K4 Alleindiät für Kaninchen, Ssniff Spezialfütter GmbH Soest, ad libitum
- Water: ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 01 March 1989 To: 15 March 1989
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 cm3
Duration of treatment / exposure:
4 hours
Observation period:
scored at 1, 24, 48 and 72 hours and after 6, 8, 10 and 14 days
Number of animals:
3
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
2
Max. score:
3
Reversibility:
not reversible
Remarks on result:
other: scabs from day 6 onwards
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
2.6
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
2
Max. score:
3
Reversibility:
not reversible
Remarks on result:
other: scabs from day 8 onwards
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24, 48 and 72 h
Score:
2.6
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24, 48 and 72 h
Score:
2
Max. score:
3
Reversibility:
not reversible
Remarks on result:
other: scabs from day 8 onwards
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
2.3
Max. score:
4
Reversibility:
not reversible

 

 

1h

 

24 h

 

48 h

 

72 h

 

6 d

 

8 d

 

10 d

 

14 d

 

 

E

O

E

O

E

O

E

O

E

O

E

O

E

O

E

O

Animal 1

3

4

2

4

2

2

2

2

3*

3

scabs

scabs

Loose scabs

Animal 2

2

4

2

4

2

2

2

2

2#

2

scabs

scabs

Loose scabs

Animal 3

2

4

2

4

2

2

2

1

3*

3

scabs

scabs

Loose scabs

*Redbraun discoloration and dryness of the skin

#Redbraun discoloration of the skin

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
The test substance is considered moderately irritant to the skin
Executive summary:

Dermal application of the test substance to rabbits resulted in erythema and necrosis after 4 hours exposure. The test substance is considered irritant to the skin.

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
01/03 1989 to 07/03 1989
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: conform guideline, non GLP
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no
Species:
rabbit
Strain:
other: white russian
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Dr. Karl Tomae GmbH Biberach
- Sex: male
- Weight at study initiation: 2.4 kg
- Housing: individual
- Diet : K4 Alleindiät für Kaninchen, Ssniff Spezialfütter GmbH Soest, ad libitum
- Water: ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 01 March 1989 To: 07 March 1989
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 cm3 in the conjunctival sac, washed with physiological saline after 72 h
Duration of treatment / exposure:
washed with physiological saline after 72 h
Observation period (in vivo):
at 1, 24, 72 h and 6 days after application
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): physiological saline
- Time after start of exposure: after 72 h

SCORING SYSTEM: draize

TOOL USED TO ASSESS SCORE: at the 72 h observation fluorescein was used to assess corneal effects
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Remarks:
chemosis and discharge
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritant / corrosive response data:
No irritant effects were observed

 

1 hour

 

Conjuntivae

24 hours

Conjuntivae

48 hours

Conjuntivae

72 hours

Conjuntivae

6 days

Conjuntivae

 

Cornea

Iris

R

C

D

Cornea

Iris

R

C

D

Cornea

Iris

R

C

D

Cornea

Iris

R

C

D

Cornea

Iris

R

C

D

Animal 1

0

0

1

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Animal 2

0

0

2

1

2

0

0

1

0

0

0

0

1

0

0

0

0

0

0

0

0

0

0

0

0

Animal 3

0

0

1

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

 

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance is not irritating to eyes.
Executive summary:

In an eye irritation test with rabbits no irritating effects of the test substance became apparent.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for selection of skin irritation / corrosion endpoint:
The test substance was irritant in a study performed according to the guideline

Justification for selection of eye irritation endpoint:
No effects were observed in a study performed according to the guideline

Effect level: empty Endpoint conclusion: Adverse effect observed

Justification for classification or non-classification

The test substance needs to be classified as H315: Causes skin irritation