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Administrative data

Description of key information

Hydroxypropyl acrylate is corrosive to skin and eyes. Hydroxypropyl acrylate may be irritating to the respiratory tract.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well documented study report, acceptable for assessment, with restrictions (occlusive exposure conditions)
Principles of method if other than guideline:
The undiluted chemical was applied to the clipped dorsal skin of two White Vienna rabbits for 1 hr under occlusive conditions. Skin reactions were scored repeatedly during the 8-day post-exposure period.
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: M.GAUKLER, 6050 Offenbach
- Weight at study initiation: approx. 3.3 kg (mean)
- Diet (ad libitum): Ssniff K, standard diet for rabbits, INTERMAST GMBH, Soest
- Water: ad libitum
Type of coverage:
occlusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
1 hour
Observation period:
8 days
Number of animals:
2
Details on study design:
TEST SITE
- Area of exposure: 2 x 2 cm, dorsal skin area
- Type of wrap if used: test patch with the test substance covered with a linen patch


REMOVAL OF TEST SUBSTANCE
- Washing: yes, with lutrol or lutrol : water (1:1)
- Time after start of exposure: 1 hr


SCORING SYSTEM: Draize scoring system
Skin readings were performed after removal of the test patch and then daily on workdays until the end of the observation period (8 days).
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24-48 h
Score:
1.5
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: desquamation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24-48 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: desquamation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24-48 h
Score:
1.5
Max. score:
4
Reversibility:
fully reversible within: 5 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24-48 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 days

Exposure: 1 hour

 

Mean erythema and edema score:

 

Score

Concentration

24 h

48 h

5 d

8 d

mean 24 – 48 h

 

[%]

Animal 1

Animal 2

Animal 1

Animal 2

Animal 1

Animal 2

Animal 1

Animal 2

Animal 1

Animal 2

erythema

100

1*

2*

2*

2*

1s

2ss

0s

1s

1.5

2

edema

100

1*

2*

2*

2*

0

1

0

0

1.5

2

 

*: extending beyond the area of application

s: desquamation

ss: severe desquamation

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well documented study report, acceptable for assessment, with restrictions (occlusive exposure conditions)
Principles of method if other than guideline:
The undiluted chemical was applied to the clipped dorsal skin of two White Vienna rabbits for 4 hrs under occlusive conditions. Skin reactions were scored repeatedly during the 8-day post-exposure period.
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: M.GAUKLER, 6050 Offenbach
- Weight at study initiation: approx. 3 kg (mean)
- Diet (ad libitum): Ssniff K, standard diet for rabbits, INTERMAST GMBH, Soest
- Water: ad libitum

Type of coverage:
occlusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
8 days
Number of animals:
2
Details on study design:
TEST SITE
- Area of exposure: 2 x 2 cm, dorsal skin area
- Type of wrap if used: test patch with the test substance covered with a linen patch


REMOVAL OF TEST SUBSTANCE
- Washing: yes, with lutrol or lutrol : water (1:1)
- Time after start of exposure: 4 hrs


SCORING SYSTEM: Draize scoring system
Skin readings were performed after removal of the test patch and then daily on workdays until the end of the observation period (8 days).
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24-48 h
Score:
3.5
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: full-thickness necrosis
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24-48 h
Score:
2.5
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: full-thickness necrosis
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24-48 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24-48 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritant / corrosive response data:
Histopathological examination of the treated skin areas confirmed the clinical findings as full thickness necrosis in both rabbits.

Exposure: 4 hours

 

Mean erythema and edema score:

 

Score

Concentration

24 h

48 h

5 d

8 d

mean 24 – 48 h

 

[%]

Animal 1

Animal 2

Animal 1

Animal 2

Animal 1

Animal 2

Animal 1

Animal 2

Animal 1

Animal 2

erythema

100

3*

2

4ns*

3*

4np*

3ss

4n,ss

4np,ss

3.5

2.5

edema

100

3

3

3

3

2

2

2

2

3

3

*: extending beyond the area of application

ns: soft necrosis

np: parchment-like necrosis, anemic

n: necrosis, anemic

ss: severe desquamation

Interpretation of results:
Category 1 (corrosive) based on GHS criteria
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well documented, acceptable study report which meets generally accepted scientific standards
Principles of method if other than guideline:
Draize Test
In general the techniques of tests as published by the FDA of the United States (Fed. Reg. 28 (119), 5582, 1963) and Draize and Kelley (Drug Cosmet. Industr. 71: 36, 1952) were followed.
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Controls:
other: The adjacent eye remaining untreated, served as a control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
once
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
2 animals
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no


SCORING SYSTEM: Ocular reactions were judged using the scoring scale as published by Draize and Kelley (Drug. Cosmet. Industr. 71: 36, 1952)
The eyes were examined at one hour, 24, 48, 72 hours and 7 days after instillation of the test material.
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24-48-72 hr
Score:
2
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24-48-72 hr
Score:
1.7
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24-48-72 hr
Score:
1
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24-48-72 hr
Score:
1
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24-48-72 hr
Score:
2
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24-48-72 hr
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24-48-72 hr
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24-48-72 hr
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24-48-72 hr
Score:
57
Max. score:
110
Reversibility:
not reversible
Irritant / corrosive response data:
During the first day after instillation the eyes showed slight or moderate corneal damage, slight iritis and severe lesions of the conjunctivae.
In the course of the seven-day observation period the degree of the ocular lesions remained unchanged or decreased very slightly. After seven days the following ocular lesions were observed: moderate opacity of the cornea, slight iritis and moderate to severe conjunctivitis.
Because of these findings it was decided to use only two rabbits instead of six.

Time

Rabbit no.

Cornea

Iris

Conjunctivae

Total score

 

 

Opacity

Area

 

Redness

Chemosis

Discharge

 

1 hr

1

1

4

1

2

3

2

39

2

1

4

1

2

4

2

41

 

 

 

 

 

 

 

 

 

24 hr

1

2

4

1

2

4

2

61

2

1

4

1

2

4

2

41

 

 

 

 

 

 

 

 

 

48 hr

1

2

4

1

2

4

2

61

2

2

4

1

2

3

3

61

 

 

 

 

 

 

 

 

 

72 hr

1

2

3

1

2

4

2

51

2

2

4

1

2

2

3

59

 

 

 

 

 

 

 

 

 

7 d

1

2

3

1

2

4

2

51

2

2

4

1

1

2

2

55

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards, well documented and acceptable for assessment
Principles of method if other than guideline:
BASF-Test
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMAL
- Body weight at study initiation: 2.98 kg (mean of 2 rabbits)


ENVIRONMENTAL CONDITIONS
no details given
Vehicle:
unchanged (no vehicle)
Controls:
other: The adjacent, saline treated eye of same animals served as control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µl
Duration of treatment / exposure:
once
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
2 animals
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: The original BASF grading was converted into the numerical grading according to the OECD Draize system.
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24-48 hr
Score:
2
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24-48 hr
Score:
2.5
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24-48 hr
Score:
0
Max. score:
2
Reversibility:
other: iritis observed on day 5 after application, not reversible
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24-48 hr
Score:
0.5
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24-48 hr
Score:
1.5
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24-48 hr
Score:
2
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24-48 hr
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 5 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24-48 hr
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days

Mean scores after 24, and 48 h*:

 

Scores

24 h

48 h

mean

 

Animal 1

Animal 2

Animal 1

Animal 2

Animal 1

Animal 2

Conjunctivae

1**

2

2**

2

1.5

2

Cornea

2

2

2

3

2

2.5

Chemosis

2

2

2

2

2

2

Iritis

0

0

0

1

0

0.5

Discharge

greasy overlay

greasy overlay

suppuration

greasy overlay

-

-

*72 hrs-scores were missing in the raw data.

** Nictitating membrane white

 

 

 

Findings at test termination:

 

Scores

8 d

Additional Findings

 

Animal 1

Animal 2

Animal 1

Animal 2

Conjunctivae

2

2

-

-

Cornea

3

3

loss of corneal tissue

-

Chemosis

0

0

-

-

Iritis

1

1

ciliary injection

-

Discharge

greasy overlay

greasy overlay

-

-

 

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation:

Several studies demonstrated that undiluted hydroxypropyl acrylate is severely irritating or corrosive to skin. The key study is summarized below.

Undiluted hydroxypropyl acrylate was applied to the skin of New Zealand White rabbits with an occlusive covering for one and four hours, respectively (BASF AG 1980). Skin readings were performed after removal of the test patch and then daily on workdays until the end of the observation period (8 days) and skin reactions were scored according to the Draize scoring system. After the 4-hour application full-thickness necrosis was observed in both treated animals at test termination. Erythema scores for the time period 24-48 hrs in the two animals were 2.5 and 3.5, respectively, and edema scores for the same skin readings were 3.0 and 3.0, respectively. After the 1-hour application erythema scores (24-48 hrs ) were 1.5 and 2, respectively, and edema scores were also 1.5 and 2, respectively. Erythema was not completely reversible until test termination, and at the end of the observation period desquamation was observed on both animals.

Taking together the results of both studies, it is concluded, that the test substance is corrosive (cat. 1C).

Eye irritation:

Several studies have shown that undiluted hydroxypropyl acrylate is severely irritating and can cause serious damage to the eye. The two most reliable studies are summarized below.

Undiluted hydroxypropyl acrylate (0.05 mL) was instilled into one eye of two rabbits. The adjacent eyes were treated with saline and served as control. The eyes were not washed out after 24 hours as specified in OECD Guideline 405. Mean scores for cornea, iris, conjunctivae and chemosis (24-48 hours) were 1.75, 0.25, 2.25, and 2.0, respectively. After 8 days the cornea showed severe opacity (mean score 3.0), and in one animal loss of corneal tissue was diagnosed. In addition, slight iritis (mean score 1) and moderate lesions of the conjunctivae were noticeable (mean score 2) (BASF AG, 1974).

In another study HPA was investigated in a Draize test in New Zealand Albino rabbits. In general the techniques of tests as published by the FDA of the United States (1963) and Draize and Kelley (1952) were followed. The undiluted substance (0.1 mL) was instilled into the conjunctival sac of one eye in two rabbits (BASF AG 1978). The eyes were not washed out and examined at one hour, 24, 48, 72 hours and 7 days after instillation of the test material. During the first day after instillation the eyes showed slight or moderate corneal damage, slight iritis and severe lesions of the conjunctivae. In the course of the seven-day observation period the degree of the ocular lesions remained unchanged or decreased very slightly. Mean scores (24-48-72 hrs) for cornea, iris, conjunctivae and chemosis were 1.85, 1.0, 2.0, and 3.5. After seven days the following ocular lesions were observed: moderate opacity of the cornea, slight iritis and moderate to severe conjunctivitis. Undiluted hydroxypropyl acrylate caused severe irritation with corneal injury when instilled directly into the eyes of laboratory rabbits. Thus, based on the presented experimental evidence, HPA was assessed to have the potential to cause serious eye damage.

- FDA of the United States, Fed. Reg. 28 (119), 5582, 1963

- Draize and Kelley, Drug Cosmet. Industr. 71: 36, 1952

Respiratory irritation:

There exists no standard test method for the assessment of respiratory irritation. There is some evidence from several inhalation hazard tests that hydroxypropyl acrylate vapours may be irritating to the nose and respiratory tract of rats (BASF AG 1974, Union Carbide Corporation 1971). This assessment is confirmed by data on the structural analogue 2-hydroxyethyl acrylate. Since the substance is classified as corrosive, the potential to cause respiratory tract irritation is implicitly covered.


Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Justification for classification or non-classification

Based on the available data, the substance has to be classified as Skin and Eye Corr. 1B: H314: Causes severe skin burns and eye damage according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.