1,2,4-trichlorobenzene

Endpoint summary

Description of key information

- Skin irritation: slightly irritant (OECD 404 / non-GLP / K2) (Korte & Greim, 1981)

- Eye irritation: not irritant (OECD 405 / non-GLP / K2) (Korte & Greim, 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:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

Acclimation period not reported, detailed test results are not available

GLP compliance:

no

Remarks:

GLP was not mandatory at the time of the study

Species:

rabbit

Strain:

other: White Russian

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2.5-2.8 kg
- Housing: V2A-Steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): 60 ± 5 %
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light

Type of coverage:

other: see "details on study design"

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 g

Duration of treatment / exposure:

4 hours

Observation period:

14 days. With the persistence of skin damage the examination period was extended until full recovery.

Number of animals:

6

Details on study design:

TEST SITE
In order to test the skin compatibility to 1,2,4-trichlorobenzene, the patch-test procedure was performed. 0.5 g of the test substance was applied on an approximately 6 cm² linen patch. The linen patch was covered with an equally large plastic film by means of a rubberized bandage (Leukoplast, P. BEIERSDORF AG & CO., Unna Straße 48, D-2000 Hamburg) and attached on the shaved skin of the back of the animals between the front and hind limbs. The linen patch stayed 4 hours on the skin. During this time the animals were kept in a rabbit-case, where although some freedom of movement was allowed, a rotation of the whole body was not possible. The head of the animals was not fixed in a special way.

SCORING SYSTEM: Draize score. For further details see "Any other information on materials and method incl. tables"

Irritation parameter:

erythema score

Basis:

mean

Remarks:

6 animals

Time point:

other: 30-60 min, 24, 48, 72, and 96 hours, 7 and 14 days

Score:

1

Max. score:

4

Reversibility:

not specified

Remarks on result:

other: The mean erythema score of 6 animals was measured at 30-60 min, 24, 48, 72, and 96 hours, 7 and 14 days

Irritation parameter:

edema score

Basis:

mean

Remarks:

6 animals

Time point:

other: 30-60 min, 24, 48, 72, and 96 hours, 7 and 14 days

Score:

1

Max. score:

4

Reversibility:

not specified

Remarks on result:

other: The mean edema score of 6 animals was measured at 30-60 min, 24, 48, 72, and 96 hours, 7 and 14 days

Irritant / corrosive response data:

1,2,4-trichlorobenzene caused slight redness and slight oedema

Detailed results are not available

Interpretation of results:

GHS criteria not met

Executive summary:

Korte & Greim (1981):

 

In order to test the skin compatibility to 1,2,4-trichlorobenzene, a the patch-test procedure was performed according to OECD guideline 404 with deviations (Analytical purity and acclimation period not reported, detailed test results are not available).

5 g of the test substance was applied on an approximately 6 cm² linen patch.

Detailed test results are not available. However the test substance substance caused slight redness and slight oedema. Thus no classification is indicated according to the GHS classification criteria for effects after a single exposure.

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:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

No GLP. Results were not reported in detail. Not all mandatory timepoints are given.

GLP compliance:

no

Remarks:

GLP was not mandatory at the time of the study

Species:

rabbit

Strain:

other: white Russian

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2.5-2.8 kg
- Housing: animals were individually housed in V2A-Steel cages (floor area 0.4 m²)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C
- Humidity (%): 60%± 5%
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light

Vehicle:

other: no data. The right eye was used as control and was treated with 0.1 mL NaCl isotonic solution

Controls:

other: the right eye was used as control

Amount / concentration applied:

TEST MATERIAL
- Concentration (if solution): 100 mg/ 0.1 mL

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

until 72 hours

Number of animals or in vitro replicates:

6

Details on study design:

Prior to the application and 1, 24, and 72 hours after application, the eyes were ophthalmologic investigated. The eye response was reviewed by 2 independent investigators. In the event of discrepancies in the assessment was the mean value was calculated.

24 hours after application the eye was also treated with fluorescein (Fluorescein Sodium eye solution USP) and then investigated.

The evaluation of the eye response was similar to the Draize scheme:

1) CORNEA Assessment

Opacity
No Opacity 0

Scattered or diffuse 1*
opacities, iris still
clearly visible

Not entirely transparent areas, 2*
details of iris indistinct

Opalescent area, details of 3*
iris not visible,
Size of the pupil difficult to
determine

Opaque, invisible iris 4*


2) IRIS
Normal 0

Abnormal wrinkle formation,
congestion, 1*
swelling, vascular injection,
iris still reacts to light


No reaction to light, haemorrhage, 2*
severe destruction

3) CONJUNCTIVA
Erythema

Normal vessels 0

Hyperaemia 1
Diffuse redness, individual 2*
vessels can not be distinguished


massive redness all sections 3*

Swelling: lids and /or nictitating membrane

No swelling

Light swelling
(inclusive of nictitating membrane) 1

Externally visible swelling with 2*
exstrophy of the lids

Swelling that causes half-close lids 3*

Swelling that causes more then half-close 4*
to complete closed lids

The grades marked with * are considered positive reactions evaluated

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

6 animals

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

not specified

Irritant / corrosive response data:

There were no effects on the cornea or iris; test scores for conjunctiva redness and oedema were 1 and 0-2, respectively. 1,2,4-trichlorobenzene resulted in a slight irritation. Fluorescein test was negative.

Detailed test results are not available

Interpretation of results:

GHS criteria not met

Executive summary:

Korte & Greim (1981)

 

The irritation/ corrosion potential of 1,2,4-trichlorobenzene was investigated with acute irritation/corrosion according to OECD 405 with deviations 1,2,4-TCB (No GLP. Results were not reported in detail), resulted in a slight irritation. There were no effects on the cornea or iris; test scores for conjunctiva redness and oedema were 1 and 0-2, respectively. Detailed test results are not available. 1,2,4-TCB was found to be non-irritating to the eye according to the GHS criteria.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation:

A key study was identified (Korte and Greim, 1981). In this study, conducted according to OECD TG 404, the substance caused only slight redness and slight oedema.

No additional reliable study was reported in the EU RAR, however it was noted that repeated exposure may cause skin effects.

 

Eye irritation:

A key study was identified (Korte and Greim, 1981). In this study, conducted according to OECD TG 405, the substance only caused slight irritation.

No additional reliable study was reported in the EU RAR.

Justification for classification or non-classification

Harmonised classification:

The substance is classified as Skin irritant 2 (H315: Causes skin irritation) according to according to the Regulation (EC) No. 1272/2008 (CLP). 

The substance has no harmonised classification for eye irritation according to the CLP. 

 

Self classification:

Based on the key studies the substance should not be classified regarding both skin and eye irritation according to the CLP and to the GHS. However, EUH066 applies (Repeated exposure may cause skin dryness or cracking). 

No data was available regarding respiratory irritation, however the substance not being classified for skin and eye irritation, no classification is expected for respiratory irritation.