Registration Dossier

Administrative data

Description of key information

SKIN

A skin irritation study conducted on rabbits performed according to US EPA TSCA Health Effects Test Guidelines elicited no dermal irritation.

EYE

An eye irritation study conducted on rabbits performed according to US EPA TSCA Health Effects Test Guidelines indicated that the material is not irritating.

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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
other: 1982 and 1984 EPA TSCA Health Effects Test Guidelines (EPA Report 560/6-84-002 and 560/6-82-001)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Male and female New Zealand White rabbits, approximately 12 to 18 weeks of age, weighing 2.0 to 3.0 kg were obtained from Hazleton-Dutchland, Inc. The animals were acclimated for at least five days and individually housed in cages with wire floors. They were maintained on rabbit diet and provided water (municipal) ad libitum. Room temperature ranged from 67 °F to 70 °F and the relative humidity ranged between 48-56%. Room lights were on a 12-hour cycle.
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
Six rabbits were dosed with 0.5 g of test material moistened with distilled water on the shaved dorsal area of the trunk. A one-inch square gauze patch was placed over the dose site and secured with adhesive tape. Plastic sheeting was secured loosely around the trunk of each animal.
Duration of treatment / exposure:
The exposure time was four hours.
Observation period:
Dermal scores were recorded at 1, 24, 48 and 72 hours after the end of the contact period.
Number of animals:
6
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No erythema/edema was observed for any animal at any time period.
Interpretation of results:
other: Not classified according to EU criteria
Conclusions:
Under the conditions of this study, the test material is considered to be a non-irritant.
Executive summary:

The skin irritation potential of the test material was investigated in accordance with the US EPA TSCA Health Effects Test Guidelines under GLP conditions (Bushy Run Research Center, 1988).

Six New Zealand White rabbits were dosed with the test material in a semi-occlusive fashion for four hours. Dermal scores were recorded at 1, 24, 48 and 72 hours after the end of the contact period.

No erythema/oedema was observed for any animal at any time period.

Under the conditions of this study, the test material is considered to be a non-irritant.

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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
other: 1982 and 1984 EPA TSCA Health Effects Test Guidelines (EPA Report 560/6-84-002 and 560/6-82-001)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Male and female New Zealand White rabbits, approximately 12 to 18 weeks of age, weighing 2.0 to 3.0 kg were obtained from Hazleton-Dutchland, Inc. The animals were acclimated for at least five days and individually housed in cages with wire floors. They were maintained on rabbit diet and provided water (municipal) ad libitum. Room temperature ranged from 67 °F to 70 °F and the relative humidity ranged between 48-56%. Room lights were on a 12-hour cycle.
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
Six rabbits were dosed with 0.1 mL (equivalent to 60 mg) of test material per eye. The test material was placed in the conjunctival sac of the eye and the lids were held together for one second. One eye was dosed, per rabbit, with test material, while the other eye served as a control.
Observation period (in vivo):
Eye irritation scores were recorded at 1, 24, 48 and 72 hours and at 7 days post-dose. Fluorescein staining was included at one day and subsequent days.
Number of animals or in vitro replicates:
Six
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Treatment with BPA-DA resulted in no corneal injury in any of the 6 rabbit eyes. Two rabbits developed iritis in the treated eye and all six rabbits displayed minor conjunctival irritation, with minor to moderate discharge. All six treated eyes were healed after 24 hours.
Other effects:
One animal was found dead on Day 6, this was not considered to be treatment-related.

Rabbit No.

87-33761

87-33762

87-33763

87-33780

87-33781

87-33782

Mean

Score/Effects at 1 Hour

Cornea:

Opacity

0

0

0

0

0

0

0.0

Area

0

0

0

0

0

0

0.0

Iris:

Inflam.

0

1

0

0

1

0

0.3

Conjunct:

Redness

1

1

1

1

1

1

1.0

Chemosis

1

1

1

1

1

0

0.8

Discharge

3

2

2

1

1

1

1.7

Score/Effects at 24 Hours

Mean

Cornea:

Opacity

0

0

0

0

0

0

0.0

Area

0

0

0

0

0

0

0.0

Iris:

Inflam.

0

0

0

0

0

0

0.0

Conjunct:

Redness

0

0

0

0

0

0

0.0

Chemosis

0

0

0

0

0

0

0.0

Discharge

0

0

0

0

0

0

0.0

Score/Effects at 48 Hours

Mean

Cornea:

Opacity

0

0

0

0

0

0

0.0

Area

0

0

0

0

0

0

0.0

Iris:

Inflam.

0

0

0

0

0

0

0.0

Conjunct:

Redness

0

0

0

0

0

0

0.0

Chemosis

0

0

0

0

0

0

0.0

Discharge

0

0

0

0

0

0

0.0

Score/Effects at 72 Hours

Mean

Cornea:

Opacity

0

0

0

0

0

0

0.0

Area

0

0

0

0

0

0

0.0

Iris:

Inflam.

0

0

0

0

0

0

0.0

Conjunct:

Redness

0

0

0

0

0

0

0.0

Chemosis

0

0

0

0

0

0

0.0

Discharge

0

0

0

0

0

0

0.0

Score/Effects at 7 Days

Mean

Cornea:

Opacity

0

0

0

-

0

0

0.0

Area

0

0

0

-

0

0

0.0

Iris:

Inflam.

0

0

0

-

0

0

0.0

Conjunct:

Redness

0

0

0

-

0

0

0.0

Chemosis

0

0

0

-

0

0

0.0

Discharge

0

0

0

-

0

0

0.0

Other Effects: Rabbit 33780 found dead on Day 6 from unknown causes (probably not dose-related).

Interpretation of results:
other: Not classified according to EU criteria
Conclusions:
Under the conditions of this study, the test material caused minor ocular irritancy overall and requires no classification in accordance with EU criteria.
Executive summary:

The eye irritation potential of the test material was investigated in accordance with the US EPA TSCA Health Effects Test Guidelines under GLP conditions (Bushy Run Research Center, 1988).

Six New Zealand White rabbits were dosed with 0.1 mL (equivalent to 60 mg) of test material per eye. Eye irritation scores were recorded at 1, 24, 48 and 72 hours and at 7 days post-dose. 

Treatment resulted in no corneal injury in any of the 6 rabbit eyes. At the 1 hour observation two rabbits displayed iritis in the treated eye and all six rabbits displayed minor conjunctival irritation, with minor to moderate discharge. All six treated eyes were healed after 24 hours.

Under the conditions of this study, the test material is considered to be a non-irritant. 

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin

The skin irritation potential of the test material was investigated in accordance with the US EPA TSCA Health Effects Test Guidelines under GLP conditions (Bushy Run Research Center, 1988). The study was awarded a reliability score of 1 in accordance with the criteria set forth by Klimisch et al. (1997).

Six New Zealand White rabbits were dosed with the test material in a semi-occlusive fashion for four hours. Dermal scores were recorded at 1, 24, 48 and 72 hours after the end of the contact period.

No erythema/oedema was observed for any animal at any time period.

Under the conditions of this study, the test material is considered to be a non-irritant.

 

Eye

The eye irritation potential of the test material was investigated in accordance with the US EPA TSCA Health Effects Test Guidelines under GLP conditions (Bushy Run Research Center, 1988).The study was awarded a reliability score of 1 in accordance with the criteria set forth by Klimisch et al. (1997).

Six New Zealand White rabbits were dosed with 0.1 mL (equivalent to 60 mg) of test material per eye. Eye irritation scores were recorded at 1, 24, 48 and 72 hours and at 7 days post-dose. 

Treatment resulted in no corneal injury in any of the 6 rabbit eyes. At the 1 hour observation two rabbits displayed iritis in the treated eye and all six rabbits displayed minor conjunctival irritation, with minor to moderate discharge. All six treated eyes were healed after 24 hours.

Under the conditions of this study, the test material is considered to be a non-irritant. 

Justification for classification or non-classification

In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No 1272/2008, the substance does not require classification with respect to skin or eye irritation.