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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 915-316-2 | 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
The reaction mass of Stearoylbenzoylmethane and Palmitoylbenzoylmethane is not classified as a skin or eye irritant.
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 8-FEB-94 to 11-FEB-94
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Test procedure in accordance with OECD guideline standard method and Good Laboratory Practice. No information on purity of batch of test substance but company documentation is available.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS:
- Source: Elevage Cunicole de Val de Selle (80160 Prouzel), France
- Age at study initiation: no data
- Weight at study initiation: 2.5 +- 0.3 kg
- Housing: individually in polystyrene cages (35 x 55 x 32 cm) in an environmentally controlled room
- Diet: UAR "112 C" pelleted diet (UAR, 91360 Villemoisson-sur-Orge, France), ad libitum. (composition and contaminants analysis by the supplier.
- Water: filtered drinking water (0.22 µm), ad libitum. Bacteriological and chemical analysis performed periodically.
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS:
- Temperature: 18 +- 3°C
- Humidity: 30-70 %
- Air changes: no data
- Photoperiod: 12h light-dark cycle
IN-LIFE DATES: from 8-FEB-1994 to 11-FEB-1988 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: not required since untreated left flank served as negative control
- Amount / concentration applied:
- TEST MATERIAL
-Amount applied (volume or weight with unit): 0.5 g of test substance as supplied
-Concentration (if solution): /
-pH: 4.6 (analysis at CIT) - Duration of treatment / exposure:
- 4 hours
- Observation period:
- Observation at 1, 24, 48 and 72 hours (in the absence of dermal irritation, the study is ended at 72 hours).
- Number of animals:
- 6
- Details on study design:
- TEST SITE:
- Area of exposure: one square inch (6 cm2)
- % coverage: data not available
- Type of wrap if used: gauze patch was kept in skin contact with an adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage.
REMOVAL OF TEST SUBSTANCE:
- Washing: no residual test substance was observed
- Time after start of exposure: 4 hours
SCORING SYSTEM: in accordance with Draize scale - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: Over 24 to 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: Very slight erythema (score 1) was observed only on one skin site at the 1-hour reading.
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: Over 24h to 72h.
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no edema observed at any time
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The reaction mass of Stearoylbenzoylmethane and Palmitoylbenzoylmethane is not classified as a skin irritant according to the criteria of annex VI of the Directive 67/548/CEE and according to EU Regulation 1272/2008 (CLP).
- Executive summary:
RHODIASTAB X5 has been tested for acute skin irritation on 3 male New Zealand White rabbits, according to O.E.C.D. guideline Nb.404 and Directive 67/548/EEC and in compliance with Good Laboratory Practice. The test substance was applied as supplied, on a compress moistened with water, in a single dermal dose of 0.5 g, to a 6 cm2clipped area of the right flank skin during 4 hours under a semi-occlusive dressing. The untreated left flank served as negative control. The cutaneous examinations were performed 1, 24, 48 and 72 hours after removal of the dressing.
No edema was noted. Erythema score 1 was observed only at one hour in one animal. The mean individual score calculated for 24-48-72 hours was 0.0-0.0-0.0 for erythema and 0.0-0.0-0.0 for edema.
Based on these results, the reaction mass of Stearoylbenzoylmethane and Palmitoylbenzoylmethane is not classified as a skin irritant according to Annex VI of the Directive 67/548/CEE and according to EU Regulation 1272/2008 (CLP).
Reference
Table 7.3.1/1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test
Score at time point / Reversibility |
Erythema |
Edema |
Max. score: 4 |
Max. score: 4 |
|
24 h |
0/0/0 |
0/0/0 |
48 h |
0/0/0 |
0/0/0 |
72 h |
0/0/0 |
0/0/0 |
Average 24h, 48h, 72h |
0-0-0 |
0-0-0 |
Reversibility | NA | NA |
NA: Not applicable
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 16-FEB-94 to 19-FEB-94
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS:
- Source: Elevage Cunicole de Val de Selle (80160 Prouzel, France)
- Age at study initiation: no data
- Weight at study initiation: 2.8 +- 0.4 kg
- Housing: individually in polystyrene cages (35 x55 x32 cm or 48.2 x 58 x 36.5 cm)
- Diet: 112C pelleted diet (UAR 91360 Villemoisson -sur-Orge,France), ad libitum.
Composition and contaminants analysis performed by the supplier.
- Water: filtered drinking water (0.22 µm), ad libitum; Bacteriological and chemical analysis performed periodically by the C.I.T.
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS:
- Temperature: 18 +- 3°C
- Humidity: 30-70 %
- Air changes: no data
- Photoperiod: 12h light-dark cycle
IN-LIFE DATES: from 16-FEB-1994 to 19-FEB-1994 - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg of cream coloured powder
- Concentration (if solution): not applicable - Duration of treatment / exposure:
- The test substance was instillated into the conjunctival sac of the right eye of each rabbit.
Scoring was performed at 24, 48, 72 hours, then on day 7 and 14 if necessary (presence of ocular lesions)
- Control animals: other: the left eye remained untreated and served as the control
- Removal of test system: no
- Scoring system: according to the Draize scale at 24, 48, 72 hours, then at 7 days as well as 14 days after the instillation if necessary
- Tool used to assess score: to determine the presence or absence of corneal opacity and to evaluate the affected area, 1 or 2 drops of 0.5 % sodium fluorescein solution can be instilled into the eye. In case of difficulty, the eye can be examined under a U.V. lamp. - Observation period (in vivo):
- 3 days (no ocular lesions observed at 72 hours)
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: /
SCORING SYSTEM: according to the Draize scale at 24, 48, 72 hours, then at 7 days as well as 14 days after the instillation if necessary
TOOL USED TO ASSESS SCORE: to determine the presence or absence of corneal opacity and to evaluate the affected area, 1 or 2 drops of 0.5 % sodium fluorescein solution can be instilled into the eye. In case of difficulty, the eye can be examined under a U.V. lamp. - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.57
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: Mean individual scores: 1-0-0.7
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: Mean individual scores: 0.3-0-0
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The reaction mass of Stearoylbenzoylmethane and Palmitoylbenzoylmethane is not classified as eye irritant according to Annex VI of the Directive 67/548/CEE and according to EU Regulation 1272/2008 (CLP).
- Executive summary:
Rhodiastab X5 has been tested for acute ocular irritation on 3 New-Zealand White rabbits, according to O.E.C.D. guideline Nb.405 and in compliance with Good Laboratory Practice. The test substance was instilled as supplied in a single dose of0.1 g, into the conjunctival sac of the left eye of the animals. The eyes were not rinsed after the instillation. Ocular examinations were performed 1, 24, 48 and 72 hours after the administration. The mean individual score values were calculated for 24, 48 and 72 hours.
Slight to moderate conjunctival irritation (scores of 1 or 2 for chemosis and redness) occurred in all animalsat 1hour. Only one animal still showed chemosis (score 1) and redness (score 2) at 24 hours while the second animal showed only slight redness (score 1) without chemosis and the third didn't show any ocular lesions. Slight redness (score 1) was still observed up to 48 hour in both rabbits.
No iridial lesions or opacity of the cornea were observed. A discharge (score 1 or 2) was notedat 1hour in all animals, and up to 24 hours in one animal with whitish purulent discharge.
Based on these results, the reaction mass of Stearoylbenzoylmethane and Palmitoylbenzoylmethane is not classified as eye irritant according to Annex VI of the Directive 67/548/CEE and according to EU Regulation 1272/2008 (CLP).
Reference
Table 7.3.2/1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test
Score at time point / Reversibility |
Cornea |
Iris |
Conjunctivae |
Chemosis |
Max. score: 4 |
Max. score: 2 |
Max. score: 3 |
Max. score: 4 |
|
24 h |
0/0/0 |
0/0/0 |
2/0/1 |
1/0/0 |
48 h |
0/0/0 |
0/0/0 |
1/0/1 |
0/0/0 |
72 h |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
Average 24h, 48h, 72h |
0-0-0 |
0-0-0 |
1-0-0.7 |
0.3-0-0 |
Reversibility*) |
- |
- |
c. |
c. |
Average time (unit) for reversion |
- |
- |
72 h. |
48 h. |
*)Reversibility: c. = completely reversible; = not completely reversible; n. = not reversible
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation:
Two in vivo studies using rabbits (OECD 404) are available for skin irritation. One study (Clouzeau, 1994) was of reliability 1 according to Klimisch cotation criteria and was therefore selected as the key study. The other study (Mercier, 1988) was of reliability 2 according to Klimisch cotation criteria and was used as a supporting study. In the key study, the test substance was applied as supplied, on a compress moistened with water, in a single dermal dose of 0.5 g, to a 6 cm2clipped area of the right flank skin of 3 male New Zealand White rabbits, during 4 hours under a semi-occlusive dressing. The untreated left flank served as negative control. The cutaneous examinations were performed 1, 24, 48 and 72 hours after removal of the dressing. No edema was noted. Erythema score 1 was observed only at one hour in one animal. The mean individual score calculated for 24-48-72 hours was 0.0-0.0-0.0 for erythema and 0.0-0.0-0.0 for edema.
In the supporting study, the test article was applied in a single dermal dose of 0.5 g, prepared as a paste with 0.23g of sterile Codex liquid paraffin, to a 6 cm2 clipped area of the intact skin of 6 rabbits, during 4 hours under a semi-occlusive dressing. The cutaneous examinations were performed 1, 24, 48 and 72 hours after removal of the dressing.
No edema was noted. Erythema score 1 was observed within a 3-day period in one animal only and at one hour and 24 hours in another animal. The mean score calculated for 24-48-72 hours was0.22for erythema and0.00for edema. Therefore the results of the supporting study are consistent with those of the key studyand support the absence of classification for skin irritation.Eye irritation:
Two in vivo studies using rabbits (OECD 405) are available for eye irritation. One study (Clouzeau, 1994) was of reliability 1 according to Klimisch cotation criteria and was therefore selected as the key study. The other study (Mercier, 1988) was of reliability 2 according to Klimisch cotation criteria and was used as a supporting study. In the key study, the test substance was instilled as supplied in a single dose of 0.1 g, into the conjunctival sac of the left eye of 3 New-Zealand White rabbits. The eyes were not rinsed after the instillation. Ocular examinations were performed 1, 24, 48 and 72 hours after the administration. The mean individual score values were calculated for 24, 48 and 72 hours. Slight to moderate conjunctival irritation (scores of 1 or 2 for chemosis and redness) occurred in all animals at 1hour. Only one animal still showed chemosis (score 1) and redness (score 2) at 24 hours while the second animal showed only slight redness (score 1) without chemosis and the third didn't show any ocular lesions. Slight redness (score 1) was still observed up to 48 hour in both rabbits. No iridial lesions or opacity of the cornea were observed. A discharge (score 1 or 2) was notedat 1hour in all animals, and up to 24 hours in one animal with whitish purulent discharge.
In the supporting study, the test substance was instilled as supplied in a single dose of 67 mg, into the conjunctival sac of the left eye of 6 New-Zealand White rabbits. Ocular examinations were performed 1, 24, 48 and 72 hours after the administration. The mean individual score values were calculated for 24, 48 and 72 hours. Slight to moderate conjunctival irritation (scores of 1 or 2 for chemosis and redness) occurred in all animals up to 24 hours. Only one animal still showed moderate redness (score 2) at 48 hours while the other animals showed only slight redness and chemosis (score 1) or no redness in one animal. Slight redness (score 1) was still observed up to 72 hour only in two rabbits and slight chemosis in one another animal. Iris congestion (score 1) with circumcorneal injections was observed in all animals at 24 hours, in 4 animals at 48 hours and was minimal only in one animal at 72 hours. No corneal opacity was observed throughout the observation period. These minimal effects still discernible at 72 hours were not considered to represent significant or irreversible irritation. Therefore the results of the supporting study are consistent with those of the key study and support the absence of classification for eye irritation.
Justification for selection of skin irritation / corrosion endpoint:
GLP-compliant study performed according to OECD 404 guideline (Klimish score = 1).
Justification for selection of eye irritation endpoint:
GLP-compliant study performed according to OECD 405 guideline (Klimish score = 1).
Justification for classification or non-classification
The incidence and severity of the signs of irritation observed among the different in vivo rabbit studies were below the criteria of Annex VI Directive 67/548/EEC or EU Regulation 1272/2008 (CLP), therefore warranting no classification for skin or eye irritation.
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.