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Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
Refer to section 13 of IUCLID for details on the read-across justification. The study with the read across substance is considered sufficient to fulfil the information requirements as further explained in the provided endpoint summary.
Reason / purpose for cross-reference:
read-across source
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
other: Federal Hazardous Substances Act , September 27, 1973
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
New Zealand White rabbits weighing 2.05 to 2.15 kg.

Type of coverage:
open
Preparation of test site:
other: abraded and non-abraded site on each rabbit
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
Single dermal application of 0.5 mL to clipped and abraded rabbit skin. No occlusion. Not stated if wash off performed.
Duration of treatment / exposure:
Single application. 24 h exposure. Not stated if wash off performed.
Observation period:
Observed at 24 and 72 h. Primary Index calculated.
Number of animals:
3 male and 3 female
Details on study design:
The site of application was clipped and abraded on all rabbits. Observations were made at 24 and 72 h following application for signs of irritation and corrosivity. Irritation scores were recorded and the primary index was calculated. The test substance was applied to the backs and occlusive wrap was not used because the test substance reacted with the dental dam creating unwanted variable. The rabbits were restrained by being put in a Newman harness for the 24 h initial exposure.
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 and 72 h
Score:
1.5
Reversibility:
other: reversibility not investigated
Irritation parameter:
erythema score
Basis:
animal: 1-6
Time point:
24 h
Score:
1.5
Max. score:
2
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: for both intact and abraded skin
Irritation parameter:
edema score
Basis:
animal: 1-6
Time point:
24 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: for both intact and abraded skin
Irritation parameter:
erythema score
Basis:
animal: 1-6
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
animal: 1-6
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Basis:
animal: 1-6
Time point:
72 h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: for noth intact and abraded skin
Irritation parameter:
edema score
Basis:
animal: 1-6
Time point:
72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
other: for both intact and abraded skin
Irritant / corrosive response data:
Well defined erythema (score 2) in 3/6 rabbits with very slight edema (score 1) in other 3/6 rabbits was apparent at 24 h. At 72 h only very slight erythema (score 1) and edema (score 1) remained. Mean value of > 1.5 - < 2.3 for erythema/eschar or for oedema from gradings in at least 2 of 3 tested animals from grades at 24, 48 and 72 h or, if reactions are delayed, from grades on 3 consecutive days after the onset of dermal reactions (when not included in the irritant category above). In this study reactions were only measured at 24 and 72 h. However, at 24 hurs 3/6 animals had a score of 2 for erythema and 3/6 a score of 1. At 24 h 6/6 had a score of 1. Therefore the mean score for 3/6 rabbits is 1.5.
Conclusions:
Based on the results of the read across study, the test substance, p-tert-butylstyrene is considered to be mild irritant.
Executive summary:

A study was conducted to determine the skin irritation/corrosion potential of the read across substance, vinyl toluene in rabbits following a single dermal exposure according to Federal Hazardous Substances Act, September 27, 1973. Six New Zealand White rabbits (2.05 to 2.15 kg) were dosed dermally with a single application of 0.5 mL of the test substance. The site of application was clipped and abraded on all rabbits. Observations were made at 24 and 72 h following application for signs of irritation and corrosivity. Irritation scores were recorded and the primary index was calculated. The test substance was applied to the backs and an occlusive wrap was not used. Reactions were only measured at 24 and 72 h. At 24 h, 3/6 animals had a score of 2 for erythema and 3/6 a score of 1. At 24 h, 6/6 had a score of 1. The calculated primary index for the test substance was 1.5 (WIL, 1977). Based on the results of the read across study, the test substance, p-tert-butylstyrene is considered to be mild irritant (WIL, 1977).

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Justification for type of information:
Justification for type of information: The study with the read across substance is considered sufficient to fulfil the information requirements.
Reason / purpose for cross-reference:
read-across source
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
summary only, lacking detail
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
New Zealand White rabbits weighing 2.00 to 2.25 kg.


Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 mL instilled in to right eye. Left eye served as untreated control. Not stated if wash out performed.
Duration of treatment / exposure:
Once only. Not stated if washout performed.
Observation period (in vivo):
Observed at 1, 24, 48 and 72 hours and 4 and 7 days.
Number of animals or in vitro replicates:
3 male and 3 female
Details on study design:
Signs of ulceration of the cornea, corneal opacity, conjunctivitis, iris irritation, chemosis, tearing and refuse color were recorded.
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
2
Reversibility:
not specified
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.66
Max. score:
4
Reversibility:
not specified
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Irritant / corrosive response data:
Immediate responses following ocular instillation – All of the rabbits closed the treated eye and preened themselves when returned to their cage. Within five minutes after instillation the rabbits had the right treated eye open. One rabbit vocalized for a few seconds when put back into its cage.

Mean Eye irritation scores for each rabbit:

Rabbit N

Mean of Score at 24, 48 and 72 Hours

Corneal Opacity

Iris Lesion

Conjunctivae

Chemosis

Erythema

Discharge

1

0

0

0

0

0.33

2

0

0

0

1

0.66

3

0

0

0

0.33

0

4

0

0

0

0

0

5

0

0

0

1

0

6

0

0

0

0.33

0.33

Conclusions:
Under the study conditions, there were signs of immediate discomfort (closing of eye, vocalisation) and slight chemosis, erythema and discharge, However, the maximum scores given were 1 and all signs were reversible within 7 d.
Executive summary:

A study was conducted to determine the eye irritation potential of the read across substance, p-methylstyrene in rabbit following a single ocular exposure according to Federal Hazardous Substances Act, September 27, 1973. Three male and 3 female New Zealand White rabbits were exposed to 0.1 mL of the test substance instilled into the right eye. It was not stated whether a wash out was performed. Under the study conditions, there were signs of immediate discomfort (closing of eye, vocalisation) and slight chemosis, erythema and discharge, However, the maximum scores given were 1 and all signs were reversible within 7 d (Adamik, 1977).

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

A study was conducted to determine the skin irritation/corrosion potential of the read across substance, vinyl toluene, in rabbits following a single dermal exposure according to the Federal Hazardous Substances Act, September 27, 1973. Six New Zealand White rabbits (2.05 to 2.15 kg) were dosed dermally with a single application of 0.5 mL of the test substance. The site of application was clipped and abraded on all rabbits. Observations were made at 24 and 72 h following application for signs of irritation and corrosivity. Irritation scores were recorded and the primary index was calculated. The test substance was applied to the backs and an occlusive wrap was not used. Reactions were only measured at 24 and 72 h. At 24 h, 3/6 animals had a score of 2 for erythema and 3/6 a score of 1. At 24 h, 6/6 had a score of 1. The calculated primary index for the test substance was 1.5 (Welcome Independent Laboratories, 1977).

Eye irritation

A study was conducted to determine the eye irritation potential of the read across substance, p-methylstyrene, in rabbit following a single ocular exposure according to the Federal Hazardous Substances Act, September 27, 1973. Three male and 3 female New Zealand White rabbits were exposed to 0.1 mL of the test substance instilled into the right eye. It was not stated whether a wash out was performed. Under the study conditions, there were signs of immediate discomfort (closing of eye, vocalisation) and slight chemosis, erythema and discharge. However, the maximum scores given were 1 and all signs were reversible within 7 d (Adamik, 1977).

Justification for classification or non-classification

Based on in vivo irritation testing in rabbit with the read across substances, vinyl toluene and p-methylstyrene, the test substance does not appear to be irritating to skin or eyes to a degree triggering classification according to CLP (EC 1272/2008) criteria. However, severe irritation was noted in a 21 d repeated dose toxicity study in rabbits with the read-across substance vinyl toluene. Also, vinyl toluene has been reported to be irritating to the eyes, upper respiratory tract and skin of humans at concentrations greater than 400 ppm. Based on this additional evidence, classification as Skin Irrit. 2 – H315 (causes skin irritation) and Eye Irrit. 2 – H319 (causes serious eye irritation) is proposed.