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EC number: 403-140-4 | CAS number: 103694-68-4 MAJANTOL; MAJANTOL R
- 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 irritation in vivo: not irritating
Eye irritation in vivo: not irritating
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:
- 1985-05-01
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1981
- Deviations:
- yes
- Remarks:
- Please refer to principles of method if other than guideline
- Principles of method if other than guideline:
- Similar to OECD 404 (1981) and in compliance with GLP; 24 h application, reading time points 24 and 72 h post-application
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: not specified
- Weight at study initiation: in average 3 kg
- Housing: single housing
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: not specified
ENVIRONMENTAL CONDITIONS
- Temperature: 18 +/- 2 °C
- Humidity: 50 - 60 %
- Air changes: not specified
- Photoperiod: 12 / 12 hrs dark / hrs light - Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved only and shaved and scratched
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5 g or 0.5 mL
- Duration of treatment / exposure:
- 24 h
- Observation period:
- 7 days
- Number of animals:
- 8
- Details on study design:
- TEST SITE
- Area of exposure: back
- coverage: 2.5 x 2.5 cm
- Type of wrap used: gauze patch
REMOVAL OF TEST SUBSTANCE
- Washing: not performed
OBSERVATION TIME POINTS
24 h, 72 h and 7 days after application
SCORING SYSTEM:
- according to Draize - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: scoring at 48 h was not performed
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: scoring at 48 h was not performed
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: scoring at 48 h was not performed
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: scoring at 48 h was not performed
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: scoring at 48 h was not performed
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: scoring at 48 h was not performed
- Irritation parameter:
- erythema score
- Basis:
- animal: #7
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: scoring at 48 h was not performed
- Irritation parameter:
- erythema score
- Basis:
- animal: #8
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: scoring at 48 h was not performed
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: scoring at 48 h was not performed
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: scoring at 48 h was not performed
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: scoring at 48 h was not performed
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: scoring at 48 h was not performed
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: scoring at 48 h was not performed
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: scoring at 48 h was not performed
- Irritation parameter:
- edema score
- Basis:
- animal: #7
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: scoring at 48 h was not performed
- Irritation parameter:
- edema score
- Basis:
- animal: #8
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: scoring at 48 h was not performed
- Irritant / corrosive response data:
- No effects in regards to erythema or edema scores were observed in any of the 8 treated animals at 24 and 72 h after treatment. Neither at the shaved only nor on the shaved and scratched site.
- Other effects:
- none
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of this study the test item is not considered to be a skin irritant to rabbit skin.
- Executive summary:
The test item was applied to the skin of 8 New Zealand white rabbits for 24 h under an occlusive dressing. Treatment sites of the animal´s backs were shaved or shaved and scratched before test item application. After 24 h the treated locations were evaluated for erythema and edema formation according to Draize scoring system. Another assessment was done 72 h after treatment. At none of the time points any adverse changes were noted in any of the animals. Edema as well as erythema scores were "0" for all animals at both time points. Thus, the test is considered to not cause skin irritation based on the results of this study.
Reference
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:
- 1987-03-31
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1987
- Deviations:
- yes
- Remarks:
- please refer to "principles of method if other than guideline"
- Principles of method if other than guideline:
- study period not sufficient to evaluate (ir)revervesibility of observed effects
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: not specified
- Weight at study initiation: 2.4 - 2.6 kg
- Housing: single housing
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature: 18 +/- 2 °C
- Humidity: 50 - 85 %
- Air changes: not specified
- Photoperiod: 12 / 12 hrs dark / hrs light - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- single application, no washing
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: not done
SCORING SYSTEM: according to Draize
TOOL USED TO ASSESS SCORE: fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- other: reversibility not determinable since no further observations were made after 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- other: reversibility not determinable since no further observations were made after 72 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- other: reversibility not determinable since no further observations were made after 72 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- other: reversibility not determinable since no further observations were made after 72 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- other: reversibility not determinable since no further observations were made after 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- other: reversibility not determinable since no further observations were made after 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- other: reversibility not determinable since no further observations were made after 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- other: reversibility not determinable since no further observations were made after 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- other: reversibility not determinable since no further observations were made after 72 h
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of this study the test item is considered to be not irritating to the rabbits eye.
- Executive summary:
To assess the test item for its eye-irritation properties six New Zealand White rabbits were used. Prior to start of study and both, 24 h and 72 p.a. the eyes were examined for ocular lesions by means of fluorescein and UV-light. All other observations were performed without fluorescein. The test sample induced in the same animals slight iris-irritations and in all animals mainly slight redness and chemosis of the conjunctiva.
Reference
Table 1 Individual results
|
Hours after treatment |
||||
1 |
24 |
48 |
72 |
24/48/72 mean |
|
Animal #1 |
|||||
Cornea |
0 |
0 |
0 |
0 |
0 |
Iris |
0 |
1 |
1 |
0 |
0.67 |
Conjunctiva Redness |
2 |
2 |
2 |
2 |
2 |
Chemosis |
2 |
2 |
1 |
1 |
1.33 |
Animal #2 |
|||||
Cornea |
0 |
0 |
0 |
0 |
0 |
Iris |
0 |
1 |
0 |
0 |
0.33 |
Conjunctiva Redness |
2 |
2 |
2 |
1 |
1.67 |
Chemosis |
2 |
2 |
1 |
1 |
1.33 |
Animal #3 |
|||||
Cornea |
0 |
0 |
0 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
0 |
Conjunctiva Redness |
2 |
2 |
2 |
1 |
1.67 |
Chemosis |
2 |
3 |
2 |
1 |
2 |
Animal #4 |
|||||
Cornea |
0 |
0 |
0 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
0 |
Conjunctiva Redness |
2 |
2 |
1 |
0 |
1 |
Chemosis |
2 |
2 |
1 |
0 |
1 |
Animal #5 |
|||||
Cornea |
0 |
0 |
0 |
0 |
0 |
Iris |
0 |
1 |
0 |
0 |
0.33 |
Conjunctiva Redness |
2 |
2 |
2 |
1 |
1.67 |
Chemosis |
2 |
2 |
1 |
0 |
1 |
Animal #6 |
|||||
Cornea |
0 |
0 |
0 |
0 |
0 |
Iris |
1 |
1 |
0 |
0 |
0.33 |
Conjunctiva Redness |
3 |
3 |
2 |
1 |
2 |
Chemosis |
2 |
3 |
2 |
1 |
2 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation in vivo, RL2
The test item was applied to the skin of 8 New Zealand white rabbits for 24 h under an occlusive dressing. Treatment sites of the animal´s backs were shaved or shaved and scratched before test item application. After 24 h the treated locations were evaluated for erythema and edema formation according to Draize scoring system. Another assessment was done 72 h after treatment. At none of the time points any adverse changes were noted in any of the animals. Edema as well as erythema scores were "0" for all animals at both time points. Thus, the test is considered to not cause skin irritation based on the results of this study.
Eye irritation in vivo, RL2
To assess the test item for its eye-irritation properties six New Zealand White rabbits were used. Prior to start of study and both, 24 h and 72 p.a. the eyes were examined for ocular lesions by means of fluorescein and UV-light. All other observations were performed without fluorescein. The test sample induced in the same animals slight iris-irritations and in all animals mainly slight redness and chemosis of the conjunctiva.
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data, the test item does not require classification as skin or eye irritant according to Regulation (EC) No 1272/2008 (CLP), as amended for seventeenth time in Regulation (EU) No 2021/849.
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.