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Diss Factsheets

Administrative data

Description of key information

A reliable in vivo study according to OECD test guideline 404 for skin irritation is available.The test substance was not irritant to the skin in this study.
A reliable study was also available for eye irritation (performmed according to OECD test guideline 405). The test substance was not irritating to the eye in this study.

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:
From 08 March1988 to 15 March 1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: guideline study according OECD 404
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
3 white male New-Zealand rabbits were treated with 0.5 ml of undiluted test substance. The test item remained under semiocclusion conditions on the skin for 4 hours. Treated animals were inspected for skin effects (erythma, oedema) after removal of patches and after 1, 2, 3 and 7 days.
GLP compliance:
yes
Species:
rabbit
Strain:
other: HC:NZW
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.8 - 3.3 kg
- Housing: individually
- Diet: Standard diet ("ssniff K4") 100-120 g/animal and day
- Water: tap water ad libitum
- Acclimation period: at least 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +-2 °C
- Humidity (%): 50%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
undiluted
Duration of treatment / exposure:
4 hour(s)
Observation period:
7 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6 cm² at the flank
- Type of wrap if used: Substance applied on a Hansamed - Wundpflaster
Hypoallergen (Beiersdorf No. 2342) and fixed with Fixomull-Stretch Klebevlies, (Beiersdorf No. 2039)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes with water
- Time after start of exposure: 4 h

OBSERVATION TIME POINTS
1, 24, 48, 72 h and after 7 days
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0.9
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0 at any time point

For details on results see Illustration.

Interpretation of results:
GHS criteria not met
Conclusions:
The irritant/ corrosive effects of the test substance o-chlorotoluene were tested on the skin of male rabbits in accordance with the OECD Guideline No. 404. The test substance was applied semiocclusively to the flank of three animals for 4 h. After 1, 24, 48 and 72 h and after 7 days scoring according to Draize was performed. Mean erythema score for 24/48/72 h was 0.9, mean oedema score was 0 over the same time period. The effect was fully reversible within 7 days.
Executive summary:

The irritant/ corrosive effects of the test substance o-chlorotoluene were tested on the skin of male rabbits in accordance with the OECD Guideline No. 404. The test substance was applied semiocclusively to the flank of three animals for 4 h. After 1, 24, 48 and 72 h and after 7 days scoring according to Draize was performed. Mean erythema score for 24/48/72 h was 0.9, mean oedema score was 0 over the same time period. The effect was fully reversible within 7 days.


The substance was slightly irritating to the skin but no classification according to EU Regulation 1272/2008 (CLP) is warranted.

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
Study period:
From 08.03.1988 to 15.03.1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: guideline study according OECD 405
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
100 µl test compound was instilled into the conjunctival sac of one eye of each of 3 rabbits. the lids were then gently held together for about one second. The other eye remained untreated and served as control. The treated eye was washed out with physiological NaCl solution 24 hours after instillation of the test compound.
GLP compliance:
yes
Species:
rabbit
Strain:
other: HC:NZW
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.8 - 3.3 kg
- Housing: individually
- Diet: Standard diet ("ssniff K4") 100-120 g/animal and day
- Water: tap water ad libitum
- Acclimation period: at least 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +-2 °C
- Humidity (%): 50%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
100 µL, undiluted
Duration of treatment / exposure:
24 hour(s)
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3
Details on study design:
Comment: rinsed after (see exposure time)
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0 at any time point
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: score = 0 at any time point
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0.4
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0 at any time point
Other effects:
no data

For details on results see Illustration.

Interpretation of results:
GHS criteria not met
Conclusions:
100 µl test compound was instilled into the conjunctival sac of one eye of each of 3 rabbits. the lids were then gently held together for about one second. The other eye remained untreated and served as control. The treated eye was washed out with physiological NaCl solution 24 hours after instillation of the test compound. Mean cornea opacity score, iris score and chemosis score for 24/48/72 h were 0, mean conjunctivae score for 24/48/72 h was 0.4 and the effect was fully reversible within 7 days.
Executive summary:

 


The eye irritant/ corrosive effects of the test substance o-chlorotoluene were tested on the eyes of rabbits in accordance with the OECD Guideline No. 405. 100 µl test compound was instilled into the conjunctival sac of one eye of each of 3 rabbits. the lids were then gently held together for about one second. The other eye remained untreated and served as control. The treated eye was washed out with physiological NaCl solution 24 hours after instillation of the test compound. Mean cornea opacity score, iris score and chemosis score for 24/48/72 h were 0, mean conjunctivae score for 24/48/72 h was 0.4 and the effect was fully reversible within 7 days.


The substance was not irritating to the eye and no classification according to EU Regulation 1272/2008 (CLP) is warranted.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information


The test substance was applied semiocclusively to the flank of three animals for 4 h. After 1, 24, 48 and 72 h and after 7 days scoring according to Draize was performed. Mean erythema score for 24/48/72 h was 0.9, mean oedema score was 0 over the same time period. The effect was fully reversible within 7 days. Several Non-reliable studies (RL4) were performed with much longer exposure durations (mostly 24 h) and in some cases shorter observations periods (<7 days). Therefore, results from these studies are not considered appropriate for assessment of skin irritation/ corrosion effects.


The eye irritant/ corrosive effects of the test substance o-chlorotoluene were tested on the eyes of rabbits in accordance with the OECD Guideline No. 405. 100 µl test compound was instilled into the conjunctival sac of one eye of each of 3 rabbits. the lids were then gently held together for about one second. The other eye remained untreated and served as control. The treated eye was washed out with physiological NaCl solution 24 hours after instillation of the test compound. Mean cornea opacity score, iris score and chemosis score for 24/48/72 h were 0, mean conjunctivae score for 24/48/72 h was 0.4 and the effect was fully reversible within 7 days. These results are supported by a reliable study also in rabbits, which showed slight effects and complete reversibility 24 days.


The criteria for Irritation according to EU Regulation 1272/2008 (CLP) are not met.


Regarding respiratory irritation there are indications from the acute inhalation toxicity studies and from the developmental toxicity study in rats with inhalation exposure (Huntingdon, 1983) of effets in the repiratory tract during and after exposure (no histopathology available). However, human data are absent and the observed effects in animals are not sufficient to justify a classification for STOT SE Cat.3. In addition, two studies determining RD50 values of o-chlorotoluene are available (see chapter 7.12 additional toxicological information). According to ECHA "Guidance on the Application of the CLP Criteria" classification in STOT SE Category 3 for respiratory tract irritation is generally limited to local cytotoxic effects and not sensory irritation. Therefore, these effects do not have to be considerd for classifcation.


Justification for classification or non-classification

Due to the result of the key studies for skin and eye irritation a classification according to EU Regulation 1272/2008 (CLP) is not justified.


In addition, the substance does not need to be classified for STOT SE Cat 3 according to EU Regulation 1272/2008 (CLP).