Dichloromethylbenzene

Endpoint summary

Description of key information

In a skin irritation study according OECD Guideline 404, the test substance was found to be irritating (Ruf/Bayer AG, 1987).
Additionally this finding was supported by a skin irritation/corrosion study where the test substance was found to be irritating to the skin (Schreiber/Bayer AG, 1981).
In an eye irritation study according to OECD guideline 405 slight effects were observed, but according to classification and labeling the substance is not irritating to the eye (Ruf/Bayer AG, 1987).
In another eye irritation study the test substance was found to be non-irritating to the eye (Schreiber/Bayer AG, 1981).

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:

abraded

Vehicle:

unchanged (no vehicle)

Controls:

other: same animals served as control (one flanc: test substance, other flanc : water

Duration of treatment / exposure:

4 h

Observation period:

14 d

Number of animals:

3

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 1h, 24h, 48h, 72h, 7d, 14d

Score:

2.3

Max. score:

4

Reversibility:

not fully reversible within: 14 d

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 1 h, 24 h, 48 h, 72 h, 7 d, 14 d

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 14d

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 1h, 24h, 48h, 72h, 7d, 14d

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 14d

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: 1h, 24h, 48h, 72h, 7d, 14d

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 14d

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 1h, 24h, 48h, 72h, 7d, 14d

Score:

2.3

Max. score:

4

Reversibility:

not fully reversible within: 14d

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: 1h, 24h, 48h, 72h, 7d, 14d

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 14d

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

2.22

Max. score:

4

Reversibility:

not fully reversible within: 14 days

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 14 days

Other effects:

In all animals from day 7 up to day 14 formation of scales was observed.

Results:

Animal No/ bw/ sex	DRAIZE-grade after
	1h		24h		48h		72h		7d		14d		Irritation scores
	Er	Ed	Er	Ed	Er	Ed	Er	Ed	Er	Ed	Er	Ed	Er	Ed
F59 (3.4 kg) female	1	1	2	1	3	1	2	1	1	0	0	0	2.3	1
G53 (3.0 kg) female	1	1	2	1	2	1	2	1	2	1	0	0	2.0	1
E51 (3.8 kg) female	1	1	2	1	3	1	2	1	1	1	0	0	2.3	1

Er = Erythema

Ed = Edema

In all animals from day 7 up to day 14 formation of scales was observed.

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

Skin Irrit. 2 (not fully reversible within 14 days - formation of scales).

Executive summary:

In a skin irritation study according OECD Guideline 404, 3 female New Zealand White rabbits were treated with 500 µl of test substance to the abraded skin of one flank. The other flank served as control and was treated only with water. The test area was covered with a semiocclusive plaster. After 4 h the plasters were removed and the test areas were washed with water. Erythema and edema formation were evaluated after 24h, 48h, 72h, 7d and 14d. In all animals from day 7 up to day 14 formation of scales was observed. The test substance was found to be irritating.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (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

Vehicle:

unchanged (no vehicle)

Controls:

other: the test substance was applied to one eye, the other eye was not treated and served as control

Duration of treatment / exposure:

24 h

Observation period (in vivo):

7 d

Number of animals or in vitro replicates:

3

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: 1h, 24h, 48h, 72h, 7d

Score:

0

Max. score:

4

Reversibility:

other: no symptom seen

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: 1h, 24h, 48h, 72h, 7d

Score:

0

Max. score:

2

Reversibility:

other: no symptom seen

Irritation parameter:

other: Conjunctiva reddening

Basis:

animal #1

Time point:

other: 1h, 24h, 48h, 72h, 7d

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 7d

Remarks on result:

other: Conjunctiva reddening

Irritation parameter:

other: Conjunctiva swelling

Basis:

animal #1

Time point:

other: 1h, 24h, 48h, 72h, 7d

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48h

Remarks on result:

other: Conjunctiva swelling

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

other: 1h, 24h, 48h, 72h, 7d

Score:

0

Max. score:

4

Reversibility:

other: no symptom seen

Irritation parameter:

iris score

Basis:

animal #2

Time point:

other: 1h, 24h, 48h, 72h, 7d

Score:

0

Max. score:

2

Reversibility:

other: no symptom seen

Irritation parameter:

other: Conjunctiva reddening

Basis:

animal #2

Time point:

other: 1h, 24h, 48h, 72h, 7d

Score:

0.7

Max. score:

3

Reversibility:

fully reversible within: 72h

Remarks on result:

other: Conjunctiva reddening

Irritation parameter:

other: Conjunctiva swelling

Basis:

animal #2

Time point:

other: 1h, 24h, 48h, 72h, 7d

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 72h

Remarks on result:

other: Conjunctiva swelling

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

other: 1h, 24h, 48h, 72h, 7d

Score:

0

Max. score:

4

Reversibility:

other: no symptoms seen

Irritation parameter:

iris score

Basis:

animal #3

Time point:

other: 1h, 24h, 48h, 72h, 7d

Score:

0

Max. score:

2

Reversibility:

other: no symptoms seen

Irritation parameter:

other: Conjunctiva reddening

Basis:

animal #3

Time point:

other: 1h, 24h, 48h, 72h, 7d

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 7d

Remarks on result:

other: Conjunctiva reddening

Irritation parameter:

other: Conjunctiva swelling

Basis:

animal #3

Time point:

other: 1h, 24h, 48h, 72h, 7d

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24h

Remarks on result:

other: Conjunctiva swelling

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable - score = = at any time point

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable - score = 0 at any time point

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0.9

Max. score:

3

Reversibility:

fully reversible within: 7 days

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 2 days

Results:

			DRAIZE-Grade
Animal No./ bw/ sex	examined organ	symptom	1h	24h	48h	72h	7d	14d	21d	Irritation score
E11 (3.6 kg) female	Cornea	-cloudiness	0	0	0	0	0	-	-	0.0
		-area	0	0	0	0	0	-	-	/
	Iris		0	0	0	0	0	-	-	0.0
	Conjunctivae	reddening	1	1	1	1	0	-	-	1.0
		swelling	2	1	0	0	0	-	-	0.3
		lacrimation	2	1	0	0	0	-	-	/
C40 (3.2 kg) female	Cornea	-cloudiness	0	0	0	0	0	-	-	0.0
		-area	0	0	0	0	0	-	-	/
	Iris		0	0	0	0	0	-	-	0.0
	Conjunctivae	reddening	1	1	1	0	0	-	-	0.7
		swelling	1	1	1	0	0	-	-	0.7
		lacrimation	1	1	0	0	0	-	-	/
O41 (3.5 kg) female	Cornea	-cloudiness	0	0	0	0	0	-	-	0.0
		-area	0	0	0	0	0	-	-	/
	Iris		0	0	0	0	0	-	-	0.0
	Conjunctivae	reddening	1	1	1	1	0	-	-	1.0
		swelling	1	0	0	0	0	-	-	0.0
		lacrimation	1	1	0	0	0	-	-	/

Interpretation of results:

GHS criteria not met

Conclusions:

Slight effects were observed, but according to classification and labeling the substance is not irritating to the eye.

Executive summary:

In an eye irritation study according to OECD guideline 405 the test substance (100 µl) was applied to one eye of 3 New Zealand White rabbits. The other eye was left untreated and served as control. After 24h the treated eyes were rinsed with physiological saline solution. Examinations took place after 1h, 24h, 48h, 72h and 7d and were evaluated according to DRAIZE.

Slight effects were observed, but according to classification and labeling the substance is not irritating to the eye.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

In a skin irritation study according OECD Guideline 404, 3 female New Zealand White rabbits were treated with 500 µl of test substance to the abraded skin of one flank. The other flank served as control and was treated only with water. The test area was covered with a semiocclusive plaster. After 4 h the plasters were removed and the test areas were washed with water. Erythema and edema formation were evaluated after 24h, 48h, 72h, 7d and 14d. In all animals from day 7 up to day 14 formation of scales was observed. The test substance was found to be irritating (Ruf/ Bayer AG, 1987)..

Additionally this finding was supported by a skin irritation/corrosion study in New Zealand White rabbits where the test substance ( 500 µl) was administered to the intact and to the scarified flank skin of 6 rabbits. The test region was covered with an occlusive PVC foil. The duration of treatment was 24 h and the observation period 8 d. The erythema and edema grade was evaluated after 24, 48, 72 and 8 d. The 48 h values are not defined in the test results. The 8 d results were given, but were not taken into consideration for the primary irritation score. The score was 3.3 and after 8 d still a slight irritation with scales could be observed in the rabbits. The test substance was found to be irritating to the skin (Schreiber/Bayer AG, 1981).

In an eye irritation study according to OECD guideline 405 the test substance (100 µl) was applied to one eye of 3 New Zealand White rabbits. The other eye was left untreated and served as control. After 24h the treated eyes were rinsed with physiological saline solution. Examinations took place after 1h, 24h, 48h, 72h and 7d and were evaluated according to DRAIZE.

Slight effects were observed, but according to classification and labelling the substance is not irritating to the eye (Ruf/ Bayer AG, 1987).

This finding was supported by another eye irritation study where the test substance (100 µl) was applied to one eye of 6 male New Zealand White rabbits (average bw = 2.3 kg). The other eye was left untreated and served as control. Examinations took place with the aid of an ophthalmoscope after 24h, 48h and 72h and 8d after test start. The 8 d value was not taken into consideration for the evaluation of the irritation index which was 0.1. The test substance was found to be non-irritating to the eye (Schreiber/Bayer AG, 1981).

Effects on skin irritation/corrosion: irritating

Justification for classification or non-classification

According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification as Skin Irrit. 2 ( H315: Causes skin irritation) is justified. No classification for eye irritation is required.