α-chloro-o-xylene

Endpoint summary

Description of key information

OECD TG 404: corrosive

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

Study period:

21 Oct 1986 - 18 Nov 1986

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

according to GLP, no characterization data on test substance available

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

Adopted 12 May 1981

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Version / remarks:

Adopted 25 April 1984

Deviations:

no

GLP compliance:

yes

Specific details on test material used for the study:

clear yellow fluid
purity ca. 99% (no analytical information available)

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG, Kastengrund, conventional breeding
- Age at study initiation: ca. 3-5 months
- Weight at study initiation: 2.1 - 3.4 kg
- Housing: single
- Diet (e.g. ad libitum): Altromin 2123 diet, ad libitum
- Water (e.g. ad libitum): deionized, chlorinated water, ad libitum
- Acclimation period: not specified

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 50 ± 20
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light):12/12

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Remarks:

in the dorsal area of the rump, a ca. 25 cm2 area was shaved with electric clippers.

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): undiluted

VEHICLE
- Amount(s) applied (volume or weight with unit): none

Duration of treatment / exposure:

3 min or 4 hours

Observation period:

14 days post application

Number of animals:

3 animals (3 min), 3 animals (4 hours)

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage:
- Type of wrap if used: cellulose patch, coverd with semiocclusive wrap

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with lukewarm water
- Time after start of exposure: at the end of exposure period (3 min / 4 hrs)

OBSERVATION TIME POINTS
(indicate if minutes, hours or days) 30-60 min, 24 hours, 48 hours, 72 hours, 7 days, 14 days

SCORING SYSTEM: Similar to OECD Draize

Irritation parameter:

erythema score

Remarks:

4 hours exposure

Basis:

mean

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

not fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Irritation parameter:

edema score

Remarks:

4 hours exposure

Basis:

mean

Time point:

24/48/72 h

Score:

3.8

Max. score:

4

Reversibility:

not fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Irritation parameter:

erythema score

Remarks:

3 min exposure

Basis:

mean

Time point:

other: 30 - 60 min

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 14 days

Remarks on result:

positive indication of irritation

Irritation parameter:

edema score

Remarks:

3 min exposure

Basis:

mean

Time point:

other: 30 - 60 min

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 14 days

Remarks on result:

positive indication of irritation

Irritation parameter:

erythema score

Remarks:

3 min exposure

Basis:

mean

Time point:

24/48/72 h

Score:

3.2

Max. score:

4

Reversibility:

not reversible

Remarks:

in 1/3 animals, effects were not reversible

Remarks on result:

positive indication of irritation

Irritation parameter:

edema score

Remarks:

3 min exposure

Basis:

mean

Time point:

24/48/72 h

Score:

2.2

Max. score:

4

Reversibility:

not reversible

Remarks:

in 1/3 animals, the effects were not reversible

Remarks on result:

positive indication of irritation

Irritation parameter:

other: scar formation

Basis:

animal #3

Time point:

14 d

Remarks on result:

positive indication of irritation

Remarks:

scar formation was observed in 1/3 animals at 14 days post exposure

3 min exposure time

Time after removal of dressing	30-60’			24 h			48 h			72 h			7 d			14 d
Animal #	1	2	3	1	2	3	1	2	3	1	2	3	1	2	3	1	2	3
Erythema formation	2	2	2	3	2	4	4	4	4	2	2	4	1	1	4	0	0	4
Edema formation	1	1	1	2	0	4	2	2	4	1	1	4	0	0	4	0	0	4
Skin surface
- Dry, chapped													X	X	X	X		x
Eschar formation						X		X	X		X	X			X			x
Open wound															X
Skin detachment															X
Scar																		X
Hematoma						X			X			X			X

 

 

4 hour exposure time

Time after removal of dressing	30-60’			24 h			48 h			72 h			7 d
Animal #	1	2	3	1	2	3	1	2	3	1	2	3	1	2	3
Erythema formation	4	4	4	4	4	4	4	4	4	4	4	4	4	4	4
Edema formation	4	4	4	4	4	4	4	3	4	4	3	4	4	4	4
Skin surface
- Dry, chapped													X	X	X
Eschar formation													X	X	X
Open wound
Skin detachment
Scar														X	X
Beige skin discoloration														X	X
Hematoma	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X

Interpretation of results:

Category 1B (corrosive) based on GHS criteria

Conclusions:

Based on the effects observed and according to the criteria specified in Regulation (EC) 1272/2008 (CLP), classification as "causes severe skin burns and eye damage" (H314) is warranted.

Executive summary:

The test substance was applied to skin of rabbits for either 3 min or 4 hours under semi-occlusive dressing. Following exposure, the remaining test substance was washed off. Animals exposed for 3 min showed clear edema and very slight erythema within 1 hour, which became severe erythema and slight to severe edema within 48 hours following exposure. Two of three animals recovered within 7 days, however one animal showed severe erythema, edema and scar formation until the end of the observation period (14 days). In accordance with the criteria laid down in Regulation (EC) 1272/2008, substances causing corrosive damage to skin after 3 min incubation are to be classified in Cat. 1 for skin corrosion. Since the test substance did not show corrosive effects within 60 min following exposure, classification as Cat. 1B is warranted.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

The test substances was assessed for its corrosive properties in an OECD TG 404 study.

Following 3 minute exposure, the animals showed formation of edema and erythema. Two animals showed eschar formation within 48 hours, which did not resolve in one animal. Additionally, dry and chapped skin was observed in 2/3 animals at the end of the observation period and one animal additionally exhibited scar formation at 14 days post exposure.

Following 4 hours exposure, all animals showed severe erythema and edema formation which was not resolved at the end of observation time (7 days). Further, all animals exhibited dry, chapped skin, hematoma, and eschar formation at day 7. Scar formation and beige skin discoloration was observed in 2/3 animals.

Additionally, data on in vitro skin irritation and corrosion tests (OECD TG 431 and 439) are available. The test substance was irritating, but not corrosive based on the results of these in vitro tests.

Due to the corrosive effects observed in the in vivo study and applying the precautionary principle, the data are considered sufficient for classification of the test substance as corrosive (Cat. 1B, H314: Causes severe skin burns and eye damage).

Justification for classification or non-classification

Based on the data available and applying the critieria layed down in Regulation (EC) 1272/2008 (CLP), classification of 2 -methylbenzyl chloride as corrosive to skin Cat. 1B (H314) is warranted. In line with Annex I, section 3.3.2.3 of Regulation (EC) 1272/2008, it can be assumed that substances corrosive to skin will also cause severe eye damage. Therefore, classification of 2 -methylbenzyl chloride as Eye Damage 1 (H318) is warranted.