Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 916-632-3 | CAS number: -
- 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
No irritant potential was detected in studies on rabbit skin and eyes in vivo
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:
- 1973
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Remarks:
- Test performed before OECD and GLP guidelines. Important aspects (dosing, observation times, grading criteria) comparable with current OECD guidelines
- Qualifier:
- according to guideline
- Guideline:
- other: Regulation according to US Federal Hazardous Substance Labeling Act
- Version / remarks:
- 17.09.1964
- GLP compliance:
- no
- Remarks:
- pre-guideline study
- Species:
- rabbit
- Strain:
- not specified
- Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved intact or shaved abraded with a scarifying instrument
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 24 h
- Observation period:
- examinations: 24 and 72 h after application, i.e. 0 and 48 h after the end of treatment/exposure
- Number of animals:
- 3 males and 3 females
- Details on study design:
- 0.5 g of the test substance is spread on a 25 cm2 gauze patch, which is applied on the abraded and intact skin of 6 rabbits, clipped free of hair under occlusive conditions. After 24 hours of exposure, the patches are removed. Reactions are recorded 0 and 48 h after the end of exposure.
- Irritation parameter:
- edema score
- Basis:
- animal: # 1-6 each
- Time point:
- other: mean of 0 and 48 h after the end of exposure
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no signs of irritation (edema) at any time
- Remarks on result:
- other: intact and abraded skin
- Irritation parameter:
- erythema score
- Basis:
- animal: # 1-6 each
- Time point:
- other: mean of 0 and 48 h after the end of exposure
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no signs of irritation (erythema) at any time
- Remarks on result:
- other: intact and abraded skin
- Irritant / corrosive response data:
- No skin reactions were observed in any animal at any time point.
At the first reading after end of exposure discolored skin, caused by the test item, was noted in all animals. This effect was no longer evident at the second reading 48 hours after end of exposure. - Other effects:
- one female animal died (not test material related).
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Regulation (EC) No 1272/2008
- Conclusions:
- According to the classification criteria of Regulation (EC) No 1272/2008 the test material is not irritating to skin under these test conditions.
- Executive summary:
The test material was subject to an acute dermal irritation/corrosion test in 6 rabbits according to the regulation of the US Federal Hazardous Substance Labeling Act. Both intact and scarified skin sites of six rabbits were exposed to 500 mg test substance for 24 h under occlusive conditions and the skin responses were examined 0 and 48 h after the end of exposure. No signs of irritation were observed.
Therefore, the test item has not to be classified for skin irritation according to Regulation (EC) No 1272/2008.
- Endpoint:
- skin irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Referenceopen allclose all
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:
- guideline study with acceptable restrictions
- Remarks:
- according to OECD 405, GLP not specified
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- Directive 79/831/EEC
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- KFM
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, 4414 Fuellingsdorf, Switzerland
- Age at study initiation: 14 to 15 weeks
- Weight at study initiation: 2.5 to 2.7 kg
- Housing: iindividually in stainless steel cages equipped with an automatic cleaning and drinking system
- Diet (e.g. ad libitum): pelleted standard rabbit maintenance diet Kliba #341, batch 92/83 (Klingentalmuehle AG)
- Water (e.g. ad libitum): tap water
- Acclimation period: four days under test conditions, with a pre-treatment health examination by a veterinarian
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2°C
- Humidity (%): 55 ± 10 %
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The right eye remained untreated and was used for control purposes.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g - Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3, two females and one male
- Details on study design:
- a single dose of 0.1 g was administered to the left eye of each animal. The right eye remained untreated and was used as the reference control respectively. The eyes were not rinsed.
SCORING SYSTEM:
the eyes of each animal were examined 1, 24, 48 and 72 hours after administration. The irritation was assessed according to the OECD guideline 405. the corrosive properties of the test item and the color of the treated eyes were described and recorded.
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein
eye examinations were meda with a sllit-lamp 30 SL (C. Zeiss AG) and a Varta Cliotrix diagnostic lamp
Body weights were recorded at pre-test, day 1 and at termination of the study on a Mettler PK 4800 balance.
All animals were killed at the end of the observation period by an intraveneous injection of T61 (Hoechst) into the ear vein. - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not relevant since no signs of irritation recorded at any observation time
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not relevant since no signs of irritation recorded at any observation time
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 125 (M)
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 126 (F)
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 127 (F)
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Remarks:
- score 1 was still evident after 72 hours; but signs of irritation are regarded to reverse within a prolonged observation period of 21 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of all animals
- Time point:
- 24/48/72 h
- Score:
- 0.89
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritant / corrosive response data:
- Ocular Reactions
Blue coloured staining of the conjunctival membrane was noted in all animals at all observations.
No corneal or iridial effects were noted during the study.
Severe discharge was observed in all animals 1 hour after administration.
Moderate conjunctival irritation was noted in all treated eyes 1 hour after treatment with minimal conjunctival irritation noted at the 24 and 48 Hour observations.
2 treated eyes appeared normal at the 72-Hour observation, in one animal score 1 was still evident. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item has not to be classified as eye irritant according to Regulation (EC) no 1272/2008.
- Executive summary:
The primary eye irritation potential of the test item was investigated according to OECD test guideline No. 405 and Method B.5. The test item was applied by instillation of 0.1 g into the left eye of each of three young adult New Zealand White rabbits. Scoring of irritation effects was performed approximately 1, 24, 48, 72 hours after test item instillation.
The mean score was calculated (separately) for each animal across three scoring times (24, 48 and 72 hours after instillation) for corneal opacity, iritis, redness and chemosis of the conjunctivae. No signs of irritation were recorded for corneal opacity and iritis in all animals. The mean score for chemosis was 0.89. The mean score for conjunctival reddening was 0.67 in two animals, for the remaining animal 1.0.
The instillation of the test item into the eyes caused a severe discharge at the first examination after 1 hour. Blue coloured staining of the conjunctival membrane was noted in all animals at all observations.
With the exception of on female all signs of irritation were reversible and were no longer evident 72 hours days after treatment. Score 1.0 conjuctival reddening observed 72 hours after treatment in one animal is regarded to reverse within a prolonged observation period of 21 days.
No clinical signs of toxicity were observed.
Thus, the test item did not induce significant or irreversible damage to the rabbit eye.
According to the findings in this study, the test item does not meet the criteria for classification according to Regulation (EC) no 1272/2008.
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
Referenceopen allclose all
Table 1: individual results
rabbit no |
evaluation interval |
cornea opacity |
Iris |
conjunctivae score |
chemosis score |
discharge |
staining |
125 (M) |
1 hour |
0 |
0 |
1 |
2 |
x |
x |
126 (F) |
|
0 |
0 |
1 |
2 |
x |
x |
127 (F) |
|
0 |
0 |
1 |
2 |
x |
x |
125 (M) |
24 hours |
0 |
0 |
1 |
2 |
- |
x |
126 (F) |
|
0 |
0 |
1 |
2 |
- |
x |
127 (F) |
|
0 |
0 |
1 |
2 |
- |
x |
125 (M) |
48 hours |
0 |
0 |
1 |
0 |
- |
x |
126 (F) |
|
0 |
0 |
1 |
1 |
- |
x |
127 (F) |
|
0 |
0 |
1 |
1 |
- |
x |
125 (M) |
72 hours |
0 |
0 |
0 |
0 |
- |
x |
126 (F) |
|
0 |
0 |
0 |
0 |
- |
x |
127 (F) |
|
0 |
0 |
1 |
0 |
- |
x |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
no classification
No irritant potential was detected in studies on rabbit skin and eyes in vivo
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.