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EC number: 202-424-3 | CAS number: 95-49-8
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
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
- 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
- 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.
Reference
For details on results see Illustration.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- 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
- 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.
Reference
For details on results see Illustration.
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).
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