Diphenyl carbonate

Endpoint summary

Description of key information

SKIN

Not irritating, rabbit, OECD 404, Desai (1990)

EYE

Not irritating, rabbit, OECD 405, Desai (1990b)

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

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: adjacent area of untreated skin on each animal served as the control

Amount / concentration applied:

Concentration: 100 %
Test substance was ground to a fine powder and a dose of 0.5g was applied to each application site

Duration of treatment / exposure:

4 hour(s)

Observation period:

30-60 min, 24h, 48h, and 72h after the 4 hour exposure period

Number of animals:

6 females

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24, 48, and 72h

Score:

0

Max. score:

8

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

none

Other effects:

none

Interpretation of results:

other: Not irritating according to EU criteria

Conclusions:

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

Executive summary:

The skin irritation potential of the substance was investigated in a study which was conducted in accordance with the standardised guideline OECD 404 under GLP conditions.

During the study six (female) New Zealand White rabbits were dosed with 0.5 g of the test material in a semi-occlusive fashion for four hours. Observations were made at 30 to 60 minutes, 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, diphenyl carbonate 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

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

females

Vehicle:

unchanged (no vehicle)

Controls:

other: The right eye remained untreated, and thus served as a control

Amount / concentration applied:

Concentration: 100 %
The test substance was ground to a fine powder and a dose of 0.1 grams was administered to the left eye of each animal.

Duration of treatment / exposure:

The eyes of the test animals were not washed out for 24 hours following instillation. 

Observation period (in vivo):

Eyes were examined at 1,  24, 48, and 72 hours after treatment using the Draize scale.

Number of animals or in vitro replicates:

6

Details on study design:

Fluorescein staining was used during each examination, excluding the 1 hour examination.

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 1, 24, 48, and 72 hours

Score:

2

Max. score:

110

Reversibility:

fully reversible within: the first 24 hours after treatment

Remarks on result:

other: Slight swelling (Grade 1) of conjunctivae was evident in the treated eyes of the test animals at 1 hour (5/6 animals) only. No signs of irritation were evident at the 24, 48, or 72 hour observation points, therefore the study was not continued

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Other effects:

none

Interpretation of results:

other: Not irritating according to EU criteria

Conclusions:

Under the conditions of this study, diphenyl carbonate is not irritating to the eyes of rabbits.

Executive summary:

The eye irritation potential of the substance was investigated in a study which was conducted in accordance with the standardised guideline OECD 405 under GLP conditions.

The test material was ground to a fine powder and a dose of 0.1 grams was administered into the left eye of six female New Zealand White rabbits. The eyes were examined at 1, 24, 48, and 72 hours after treatment using the Draize scale. Slight swelling (Grade 1) of conjunctivae was evident in the treated eyes of the test animals at 1 hour (5/6 animals) only. No signs of irritation were evident at the 24, 48, or 72 hour observation points.

Under the conditions of this study, diphenyl carbonate is not irritating to the eyes of rabbits.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin Irritation

The skin irritation potential of diphenyl carbonate is addressed with two studies.

 

The key study (Desai, 1990) was conducted in accordance with the standardised guideline OECD 404 under GLP conditions. It was awarded a reliability score of 1 in accordance with the criteria for assessing data quality as set forth by Klimisch et al. (1997).

Six (female) New Zealand White rabbits were dosed with 0.5 g of the test material in a semi-occlusive fashion for four hours. Observations were made at 30 to 60 minutes, 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, diphenyl carbonate is considered to be a non-irritant.  

 

The supporting study (Kimmerle, 1963) was awarded a reliability score of 3 in accordance with the criteria for assessing data quality as set forth by Klimisch et al. (1997). The test appears to have significant methodological deficiencies but only limited data is available.

The test was performed using one rabbit; the solid was moistened with water (left ear) or oil (right ear) and applied to the external ear on a gauze patch. The gauze patch was fixed with a tape during the exposure period (24 h). The animals were observed for 7 days. Immediately after the patch was removed slight erythema and oedema was observed at both ears. At the right ear these signs of irritation lasted for 24 hours and disappeared after 48 hours.

Under the conditions of this study, slight signs of irritation were observed.  

 

Eye Irritation

The eye irritation potential of diphenyl carbonate is addressed with two studies.  

 

The key study (Desai, 1990b) was conducted in accordance with the standardised guideline OECD 405 under GLP conditions. It was awarded a reliability score of 1 in accordance with the criteria for assessing data quality as set forth by Klimisch et al. (1997).

The test material was ground to a fine powder and a dose of 0.1 grams was administered into the left eye of six female New Zealand White rabbits. The eyes were examined at 1, 24, 48, and 72 hours after treatment using the Draize scale. Slight swelling (Grade 1) of conjunctivae was evident in the treated eyes of the test animals at 1 hour (5/6 animals) only. No signs of irritation were evident at the 24, 48, or 72 hour observation points.

Under the conditions of this study, diphenyl carbonate is not irritating to the eyes of rabbits.

 

The supporting study (Kimmerle, 1963) was awarded a reliability score of 4 in accordance with the criteria for assessing data quality as set forth by Klimisch et al. (1997).

The species used for this test was the rabbit. The test material was placed in the conjunctival sac. After 1 hour the eye was washed out with water. No irritation of the conjunctivae and no corneal lesions were observed.

Under the conditions of this study, diphenyl carbonate is considered to be not irritating.

 

Respiratory Irritation

No data are available with regard to respiratory tract irritation. Based on the toxicological data available for other routes, it is not considered to be likely that the substance will cause irritation to the respiratory tract. 

Justification for selection of skin irritation / corrosion endpoint:

The key study was selected on the basis that it was performed in accordance with a standard guideline under GLP conditions. It was awarded a reliability score of 1 in accordance with the criteria for assessing data quality as set forth by Klimisch et al. (1997).

Justification for selection of eye irritation endpoint:

The key study was selected on the basis that it was performed in accordance with a standard guideline under GLP conditions. It was awarded a reliability score of 1 in accordance with the criteria for assessing data quality as set forth by Klimisch et al. (1997)..  

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.