Registration Dossier

Administrative data

Description of key information

Animal and human data are available to evaluate skin irritation. DBPP is considered not irritant for the skin.
Two K4-ranked in vivo studies are available for eye irritation. A weight-of-evidence approach was applied. DBPP is considered to be not an eye irritant.

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:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
1979
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: The study protocol is poorly documented.
Justification for type of information:
Acryloid HF-422 (70.8% dibutylphenylphosphate and 29.2% n-butylmethacrylate polymer) is considered a suitable RA test substance based on the present % of DBPP.
Reason / purpose:
read-across source
Remarks:
RA RSS and original RSS are identical
Qualifier:
no guideline followed
Principles of method if other than guideline:
Primary skin irritation test. Erythema and edema were scored on intact and abraded skin of New Zealand rabbits after 24 and 72 h.
GLP compliance:
no
Species:
rabbit
Strain:
other: New Zealand
Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
0.5 mL applied
Number of animals:
6 animals: 3 males and 3 females
Details on study design:
SCORING SYSTEM: max. score = 8, erythema + edema
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
ca. 1
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
ca. 0
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
ca. 0
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
72 h
Score:
ca. 1
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Score:
ca. 0

h

24

72

 

ERYTHEMA

EDEMA

ERYTHEMA

EDEMA

 

intact

abraded

intact

abraded

intact

abraded

intact

abraded

1 male

1

1

0

0

0

0

0

0

2 male

0

1

0

0

0

0

0

0

3 male

0

1

0

0

0

0

0

0

4 female

0

1

0

0

0

0

0

0

5 female

0

1

0

0

0

0

0

0

6 female

1

1

0

0

1

1

0

0

Interpretation of results:
not irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Acryloid HF-422 can be classified as "non-irritant" to the skin.
Endpoint:
skin irritation: in vivo
Remarks:
In vivo study available from 1956, there is no use to perform an in vitro test
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1956
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: The study protocol is poorly documented.
Qualifier:
no guideline followed
Principles of method if other than guideline:
As described by Draize, Moodard and Calvary, J. of Pharm. & Exp. Therapeutics (1944), 82:4.
GLP compliance:
no
Remarks:
Study performed in 1956
Species:
rabbit
Strain:
not specified
Details on test animals and environmental conditions:
no information available
Type of coverage:
not specified
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Observation period:
72 hours
Number of animals:
3
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 1
Reversibility:
fully reversible within: 2 hours

Animal No. - Sex  2 hours 24 hours  48 hours  72 hours 
1 - Male  0
2 - Male 
3 - Female 
Average  0.3 
Interpretation of results:
not irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The compound was found to be practically non-irritating when applied to intact rabbit skin.
Executive summary:

After 2 hours one animal showed barely perceptible erythema. The other 2 animals received a score of zero. Overnight the trace of erythema on the affected animal disappeared.

The compound was found to be practically non-irritating when applied to intact rabbit skin.

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

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
1979
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: The study protocol is very poorly documented.
Justification for type of information:
Acryloid HF-422 (70.8% dibutylphenylphosphate and 29.2% n-butylmethacrylate polymer) is considered a suitable RA test substance based on the present % of DBPP.
Reason / purpose:
read-across source
Remarks:
RA RSS and original RSS are identical
Qualifier:
no guideline followed
Principles of method if other than guideline:
Acute eye irritation test. Cornea, iris and conjunctivae of New Zealand rabbits were scored after 24, 48 and 72 h.
GLP compliance:
no
Species:
rabbit
Strain:
other: New Zealand
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
dose: 0.1 mL
Number of animals or in vitro replicates:
6 animals: 3 males and 3 females
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24 h
Score:
ca. 1.67
Max. score:
10
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
48 h
Score:
ca. 0.83
Max. score:
5
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
72 h
Score:
ca. 0.83
Max. score:
5
Irritation parameter:
iris score
Basis:
mean
Time point:
24 h
Score:
ca. 0.83
Max. score:
5
Irritation parameter:
iris score
Basis:
mean
Time point:
48 h
Score:
ca. 0.83
Max. score:
5
Irritation parameter:
iris score
Basis:
mean
Time point:
72 h
Score:
ca. 0.83
Max. score:
5
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24 h
Score:
ca. 1
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
48 h
Score:
ca. 0.67
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
72 h
Score:
ca. 0.33
Max. score:
2

 

24

48

72

 

cornea

iris

conj.

cornea

iris

conj.

cornea

iris

conj.

1 male

0

0

2

0

0

0

0

0

0

2 male

0

0

0

0

0

0

0

0

0

3 male

10

5

2

5

5

2

5

5

2

4 female

0

0

0

0

0

0

0

0

0

5 female

0

0

2

0

0

2

0

0

0

6 female

0

0

0

0

0

0

0

0

0

Conclusions:
Acryloid HF-422 can be classified as a slight irritant to the eye.
Endpoint:
eye irritation: in vivo
Remarks:
In vivo study available from 1956, there is no used to perform an in vitro test
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1956
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Secondary source: only compilation document available.
Qualifier:
no guideline followed
Principles of method if other than guideline:
0,1 mL of undiluted sample was placed in the conjunctival sac of the right eye of each of 3 albino rabbits and the resulting irritation scored according to the method of Draize, Woodard and Calvery: J. of Pharm. & Exp. Therapeutics (1944), 82:4.
GLP compliance:
not specified
Species:
rabbit
Strain:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Duration of treatment / exposure:
not clear from secondary source compilation document
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1 hour
Score:
ca. 5.3
Max. score:
6
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24 h
Score:
ca. 2.6
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
48 h
Score:
ca. 0.6
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
72 h
Score:
ca. 0
Max. score:
0
Irritant / corrosive response data:
The animals blinked but showed no discomfort when the compound was applied. After 1 hour the average score was 5,3 out of a possible 110. There was slight redness of the conjunctivae with some discharge and a trace of swelling. Iris and cornea appeared to be unaffected. Overnite the average score dropped to 2,6 and within 48 hours two fo the 3 animals were free of inflammation. The liquid proved to be a rather mild ocular irritant.

Animal No. - Sex  1 hour  24 hour  48 hour  72 hour 
1 - Female 
2 - Male 
3 - Female  2
Average  5.3  2.6  0.6  0.0 
Interpretation of results:
slightly irritating
Remarks:
Criteria used for interpretation of results: not specified
Conclusions:
The liquid proved to be a rather mild ocular irritant.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation/corrosion

Animal data from two study reports were available. However, both were assigned a Klimisch score of 4. In the oldest study (Younger, 1956), DBPP was found to be practically non-irritating when applied to the intact skin of rabbits. In the other study (Branch, 1979), Acryloid HF-422, a formulation of 70.8% DBPP and 29.2% n-butylmethacrylate polymer, was applied on the skin of New Zealand rabbits. And also this formulation was not a skin irritant.

 

Apart from the animal data there is a repeated insult patch test with human volunteers available.

 

In the repeated insult patch test with DBPP (Shelanski, 1974), the test material was applied on the human skin of 50 human volunteers. After an exposure period of 24 h the patch was removed and the skin sites were examined. Gross changes, if present, were graded on a scale of 1 to 4. Absence of any visible changes were assigned a 0 value.

After the first exposure, no visible skin changes signifying reaction to injury were recorded.

Eye irritation

There are two in vivo eye irritation studies available (Younger, 1956; Branch, 1979). Since both were ranked with a K4 Klimisch score, a weight of evidence approach was applied.

In the oldest study (Younger, 1956), 0.1 mL of undiluted sample was placed in the conjunctival sac of the right eye of each of three albino rabbits and the resulting irritation was scored according to the method of Draize et al. (1944). Eye irritation in rabbits consisted of slight redness of the conjuctivae with some discharge and a trace of swelling for an average score after one hour of 5.3 out of a possible 110. After 48 h two of the animals were free of inflammation and after 72 h all three animals were scored 0. The author of the study report concluded that DBPP is a rather mild ocular irritant.

In the other study (Branch, 1979), 0.1 mL of Acryloid HF-422 was applied to the eyes of six New Zealand rabbits. The test substance Acryloid HF-422 is a formulation of 70.8% DBPP and 29.2% n-butylmethacrylate polymer. The average score was respectively 3.5, 2.3 and 2.0 out of a maximum score of 110 after 24, 48 and 72h.

Justification for classification or non-classification

Skin irritation/corrosion

Information from the animal studies indicated that the substance is not a skin irritant. Additionally, DBPP did not score positive after a 24h exposure period on the human skin of 50 volunteers. Based on this information, DBPP is not classified as a skin irritant according to the CLP Regulation.

Eye irritation

In both evaluated study reports, in less than 2 of 3 tested animals, a positive response of corneal opacity ≥1 and/or iritis ≥ 1 and/or conjunctival redness ≥ 2 and/or conjunctival oedema (chemosis) ≥ 2, was calculated as the mean scores following grading at 24, 48 and 72 hours. Based on these results and the criteria described in the CLP Regulation, DBPP is not classified as an eye irritant.