Registration Dossier

Administrative data

Description of key information

Skin
Rabbit, 4h, semiocclusive: slightly irritating (BASF AG 1991, according to OECD 404 and GLP)
Rabbit, 24h, occlusive: slightly irritating (BASF AG, 1994, according to Fed. Reg. and GLP)
Rabbit, 24h, occlusive: not irritating (BASF Japan, 1997, according to Code of Federal Regulations, Title 16, Section 1500.41 and GLP)
Eye
Rabbit, substance not washed out: non-irritating (BASF AG 1991, according to OECD 405 and GLP)
Respiratory System
No data available

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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptabele restrictions
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Gaukler, FRG
- Weight at study initiation: male: 2.78 kg; female: 2.66 kg
- Housing: 1 animal per cage
- Diet (e.g. ad libitum): Kliba 341, 130 g per animalper day
- Water (e.g. ad libitum): 250 ml tap water per animal per day


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin sites of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
male. 2
female: 1
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: four layers of absorbent gauze + porous bandage
Irritation parameter:
edema score
Remarks:
24 - 48- 72h
Basis:
mean
Time point:
other: 24 - 48- 72h
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 72 h
Irritation parameter:
erythema score
Remarks:
24 - 48- 72h
Basis:
mean
Time point:
other: 24 - 48- 72h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 72h

Readings:

Time

Animal No.

Erythema

Edema

4h

1

0

0

2

0

0

3

1

0

24h

1

1

0

2

0

0

3

1

0

48h

1

1

0

2

0

0

3

0

0

72h

1

0

0

2

0

0

3

0

0

Mean

 

0.3

0

 

 
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:
2 (reliable with restrictions)
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler, Offenbach, FRG
- Housing: single
- Diet (e.g. ad libitum): Kliba 241, 4MM; about 130 g per animal/per day
- Water (e.g. ad libitum): 250 ml tap water per animal/per day
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml


Number of animals or in vitro replicates:
1 male, 2 female

Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 - 48 - 72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 - 48 - 72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 - 48 - 72 h
Score:
0.3
Max. score:
1
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 - 48 - 72 h
Score:
0
Max. score:
0

Results Acute Eye irritation

Readings

Animals

Cornea

Iris

Conjunctiva

OP

AR

RED

SW

DI

1 H

1

0

0

0

2

0

2

2

0

0

0

2

0

2

3

0

0

0

2

0

2

24 H

1

0

0

0

0

0

0

2

0

0

0

1

0

0

3

0

0

0

0

0

0

48 H

1

0

0

0

0

0

0

2

0

0

0

0

0

0

3

0

0

0

0

0

0

72 H

1

0

0

0

0

0

0

2

0

0

0

0

0

0

3

0

0

0

0

0

0

ME

1

0.0

 

0.0

0.0

0.0

 

2

0.0

 

0.0

0.3

0.0

 

3

0.0

 

0.0

0.0

0.0

 

ME

 

0.0

 

0.0

0.1

0.0

 

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

There are valid in-vivo data available for the assessment of the skin and eye irritation potential.

Skin

In an acute dermal irritation or corrosion study according to OECD 404 and GLP, 0.5 ml of the test substance were topically applied to the intact skin of 3 White Vienna rabbits for 4 hours under semiocclusive dressing (BASF AG 1991). The average score (24 to 72 hours) for irritation was calculated to be 0.3 for erythema and 0.0 for edema, thus the test substance was only slightly irritating in this assay.

Two further studies are available where rabbits were treated with the test substance on abraded and non-abraded skin areas for 24h under occlusive conditions. Due to the harsh conditions compared to current guidelines and because two valid studies are available, the results were only used as supplemental information.

A single dose of 0.5 ml of the test substance applied to a 6 cm² scarified or non-scarified clipped area of the skin of 6 male New Zealand White rabbits (BASF AG 1994) caused only slight irritation. The test substance was held in contact with the skin for 24 hours by means of an occlusive hypoallergenic dressing. Cutaneous reactions were observed approximately 24 and 72 hours after application of the test substance. The Cutaneous Primary Irritation index was: 1.4. Since the animals were only observed for 72h, reactions persisted in a few rabbits until the end of the study. 

Six rabbits were each administered a dermal dose of 0.5 ml of the test substance to one intact and one abraded skin site and observed for three days (BASF Japan 1997). The method followed was that described in Code of Federal Regulations, Title 16, Section 1500.41. A single occlusive application to intact and abraded rabbit skin for twenty-four hours elicited no dermal irritation.

The Primary Irritation Index (PII) was calculated to be 0.9.

Eye:

3 white Vienna rabbits were subjected to a single ocular application of 0.1ml of the test substance on day 0 in a GLP study according to OECD 405 (BASF AG 1991) . The average scores (24 to 72h) for the first rabbit were calculated to be 0.0 for corneal opacity, 0.0 for iris.

Justification for classification or non-classification

The available data indicate a non-irritating potential of, Propylidynetrimethanol, ethoxylated, propoxylated, esters with acrylicacid, reaction products with 1-Butanamine, N-butyl- (> 1 <6.5 is not required to be classified for its eye irritation potential according to 67/548/EEC and CLP/EU-GHS requirements.

 

The available data indicate a non-irritating potential of, Propylidynetrimethanol, ethoxylated, propoxylated, esters with acrylicacid, reaction products with 1-Butanamine, N-butyl- (> 1 <6.5 is not required to be classified for its skin irritation potential according to 67/548/EEC and CLP/EU-GHS requirements.