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EC number: 214-222-2 | CAS number: 1115-20-4
- 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
skin: not irritating
eye: irreversible effects
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study is comparable to OECD Guideline 404 with acceptable restrictions (partly limited documentation, e.g. details about the test substance; exposure period 20 h and occlusive coverage conditions [worst case scenario]).
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- 20 h occlusive exposure
- Principles of method if other than guideline:
- Skin irritation was tested using an internal method (BASF test)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- One females, initial weight: 2.61 and one male, initial weight 2.84 kg
no further details - Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- 80% test substance (w/v) in distilled water was used. The application site was covered with an cotton patch of 2.5 X 2.5 cm; prior application of the test substance to the patch, amount not reported (presumably patch soaked with the test substance); no further data.
- Duration of treatment / exposure:
- 1, 5, or 15 minutes or 20 h
- Observation period:
- Results were recorded each working day for up to 7 days. Scoring was done 24 h, 48 h and 5 and 7 days after initiation.
- Number of animals:
- 2 rabbits
- Details on study design:
- After the reported exposure time, the skin was washed with 50% Lutrol in water.
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No effects were detected after 1, 5, or 15 minutes of exposure; no effects were seen after 20 h occlusive application (see Table below).
No edema was reported in any experiment. - Other effects:
- Body weight not altered.
- Interpretation of results:
- not irritating
- Conclusions:
- The test substance has no skin irritant properties.
- Executive summary:
The study is comparable to OECD Guideline 404 with acceptable restrictions (partly limited documentation, e.g. details about the test substance; exposure period 20 h and occlusive coverage conditions [worst case scenario]).
Two rabbits were dermally exposed to moistened test substance for 1, 5, 15 minutes or for 20 h. The coverage was occlusive; the skin was washed after exposure. Skin reaction was scored 24 & 48 h, and 5 and 7 days initiation. No erythema was found. No edema was reported.
Conclusion: The test substance has no skin irritant properties.
Reference
Skin erythema in 2 rabbits after dermal exposure to the undiluted test substance for 20 h followed by washing with 50% Lutrol
Time after initiation of exposure |
20 hours exposure; erythema in |
|
Rabbit 1 |
Rabbit 2 |
|
24 h |
0 |
0 |
48 h |
0 |
0 |
5 days |
0 |
0 |
7 days |
0 |
0 |
Evaluation transformed to OECD-Draize scoring; no edema reported.
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study is comparable to OECD Guideline 405 with acceptable restrictions (partly limited documentation, e.g. no details about the test substance; only 50 mg instead of 100 mg test substance instilled; not washed out but comparison with talcum powder was given; max. observation period only 8 days, 21 days recommended).
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- (scorring system); BASF-Test
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- Two males, initial bw 3.07 or 3.17 kg
no further details - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: same amount talcum powder into the conjunctival sac of the left eye
- Amount / concentration applied:
- ca. 50 mg instilled into the conjunctival sac
- Duration of treatment / exposure:
- unwashed
- Observation period (in vivo):
- up to 8 days after application; see Table in the result section.
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- The animals were observed several times on the treatment day and up to 8 days afterwards, and findings were recorded on working days.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritant / corrosive response data:
- Scar formation was observed at day 6 in animal #1; ciliary injection at day 6 and scar formation at day 8 was observed in animal #2.
Small effects were also detected in the left eye (talcum control; mechanical irritation): slight redness (Draize conjunctivae score 1) which was completely reversible within 6 days (animal #1) and 24 h (animal #2). - Other effects:
- no effects on body weight
no further data - Interpretation of results:
- highly irritating
- Conclusions:
- The instillation of 50 mg test substance into the conjunctival sac of rabbit eyes resulted in irreversible effects.
- Executive summary:
The study is comparable to OECD Guideline 405 with acceptable restrictions (partly limited documentation, e.g. no details about the test substance; only 50 mg instead of 100 mg test substance instilled).
An amount of 50 mg test substance was instilled into the right eye of 2 rabbits; the left eye served as control (50 mg talcum powder instilled). Effects were recorded 1, 24, 48, 72 h and up to 8 days after instillation. Edema and corneal opacity OECD score 2 were reported in both rabbits as well as ulceration (one rabbit) and scar formation (both rabbits). Corneal opacity was still present in both rabbits 8 days after instillation.
Conclusion: The instillation of 50 mg test substance into the conjunctival sac of the rabbit eyes resulted in irreversible effects.
Reference
Eye irritation in 2 rabbits after instillation of 50 mg test
substance
Scoring according to OECD-Draize scheme; description of
effects from raw data
Time period after application |
Rabbit 1 |
Rabbit 2 |
Erythema |
||
1 h |
1 |
1 |
24 h |
2 |
1 |
48 h |
2 |
2 |
72 h |
1 |
2 |
6 days |
1 |
1 |
8 days |
0 |
1 |
Time period after application |
Rabbit 1 |
Rabbit 2 |
Edema |
||
1 h |
2 |
1 |
24 h |
1 |
2 |
48 h |
0 |
2 |
72 h |
0 |
2 |
6 days |
0 |
1 |
8 days |
0 |
1 |
Time period after application |
Rabbit 1 |
Rabbit 2 |
Corneal opacity and other effects |
||
1 h |
1 (discharge) |
1 |
24 h |
2 (discharge) |
1 |
48 h |
2 (cornea covered by a smeary film) |
2 (discharge) |
72 h |
2 (cornea covered by a smeary film) |
2 (ulceration) |
6 days |
2 (scar formation) |
2 (ciliary injection) |
8 days |
1 (scar formation) |
2 (scar formation) |
Raw data not clearly compatible with results described in the summary protocol
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
SKIN:
Skin irritation was tested using an internal method (BASF test, 1974). Two rabbits were dermally exposed to moistened test substance for 1, 5, 15 minutes or for 20 h. The coverage was occlusive; the skin was washed after exposure (worst case scenario). Skin reaction was scored 24 and 48 h, and 5 and 7 days after initiation. No erythema was found. No edema was reported.
Conclusion: The test substance has no skin irritant properties.
EYE:
Eye irritation was tested using an internal method (BASF test, 1974). An amount of 50 mg test substance was instilled into the right eye of 2 rabbits; the left eye served as control (50 mg talcum powder instilled). Effects were recorded 1, 24, 48, 72 h and up to 8 days after instillation. Mean scores (24 -72 h of both animals) are 2 (cornea), 0 (iris), 1.7 (conjuctivae) and 1.15 (chemosis). Corneal opacity was still present in both rabbits 8 days after instillation (end of observation period).
Conclusion: The instillation of 50 mg test substance into the
conjunctival sac of the rabbit eyes resulted in irreversible effects.
Justification for classification or non-classification
The substance is not irritating to the skin but causes irreversible effects on the eye and is therefore classified as Xi R41 according to Annex VI of Directive 67/548/EWG and Eye Irritation Cat. 1 according to Annex I of Directive 1272/2008 (EU-GHS).
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