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EC number: 618-848-0 | CAS number: 92413-47-3
- 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 sensitization (OECD 406, RL1): guinea pig (m/f), not skin sensitizing
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21.05.-14.06.1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1981
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The study was conducted before the LLNA-test became mandatory.
- Species:
- guinea pig
- Strain:
- other: PDH
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: SAVO-Ivanovas, Kisslegg
- Age at study initiation: about 6 - 8 weeks
- Housing: Healthy young guinea-pigs were allocated to individual cages. They were housed under conventional conditions in a 60 m2 room with artificial light (light phase: 6 a.m.-6 p.m.) and were allowed at least 7 days of acclimatization before the start of treatment. The cages used (MakrolonR cages type IV) had a floor area of 55 x 33 cm (1815 cm2) and a height of 20 cm, and were placed on mobile racks. The room temperature during the study period was 22 - 28 °c and the relative atmospheric humidity 33 - 60 %. Temperature and atmospheric humidity were registered by a thermo-hygrograph (Type 252, Wilhelm Lambrecht KG, Göttingen).
- Diet: Altromin Standard Diet TPF (R) 3012 (see item 7) and tap water (Südhessische Gas und Wasser AG, Darmstadt and Wasserwerk E. Merck, Darmstadt) from Makrolon drinking bottles were available to the guinea-pigs ad libitum. The diet is checked periodically by an independent and German Government approved testing laboratory ,- according to the regulations of the manufacturer. Analysis includes both qualitative and quantitative evaluation for heavy metals, aflatoxins, pesticides and antibiotics. Drinking water employed in this type of study is regularly investigated microbiologically, physico-chemically, and chemically. The analytical results show that the limits set by German regulations for animal feed and by German regulations for human drinking water have not been exceeded. - Route:
- intradermal
- Vehicle:
- paraffin oil
- Concentration / amount:
- 0.05 g/100 mL
- Day(s)/duration:
- Day 1
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- 10 g/100 mL
- Day(s)/duration:
- Day 8/ 48 hours
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- 1 g/100 mL
- Day(s)/duration:
- Day 22/ 24 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Two groups of 10 males and 10 females were used.
- Positive control substance(s):
- yes
- Remarks:
- The sensitivity of the test system has been demonstrated with DNCB = 2,4 dinitro-1-chlorobenzene (challenge concentration 0.01 %) in another study
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material was not a skin sensitiser under the test conditions of this study.
- Executive summary:
Objective
The purpose of this Guinea-pig maximization test was to assess the skin sensitizing potential of the test material when applied to the skin of the animal.
This study should provide a rational basis for risk assessment to the sensitizing potential of the test item in man.
Study Design
For this purpose Induction was performed in two stages. At first the test material was intradermally injected with and without Freund's complete adjuvant. Then, after one week, the test material was topically applied under occlusive patch conditions for 48 hours. The challenge was performed two weeks later by topical application. The patches were then applied for 24 hours.
Results
induction phase:
The injection sites were swollen and red. Later necrosis and scabs were observed. Similar findings were seen with liquid paraffin. After removal of the patches redness and scales were observed at the topical application sites
after challenge:
No irritation was observed in the test group. 24 h after challenge with the test item, a barely perceptible erythema was observed in two female animals and considered as not positive. At the 48 h reading the challenge sites in two female animals were covered with scales. These reactions were evaluated as a positive skin reaction.
The total positive reaction was 5%.
Conclusion
The test material was not a skin sensitiser under the test conditions of this study.
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
Referenceopen allclose all
Findings in the induction phase
After intradermal injection the usual irritation seen after treatment with Freund's complete adjuvant was observed. The injection sites were swollen and red. Later necrosis and scabs were observed. Similar findings were seen with liquid paraffin. After removal of the patches redness and scales were observed at the topical application sites.
Positive reactions (percent) after challenge
Group Test Time points
material 24 h 48 h Total
1 Liquid paraffin 0/20 ( 0 %) 0/20 ( 0 % ) 0/40 (0%)
2 test item 0/20 ( 0 %) 2/20 (10 % ) 2/40 (5%)
Clinical findings and mortality
The clinical behavior of the guinea-pigs was normal during the study period. All animals survived the study period.
Body weight
The body weight development (Table 3) did not differ from that of the animals of the vehicle group. All animals survived the study period.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Objective
The purpose of this Guinea-pig maximization test was to assess the skin sensitizing potential of the test material when applied to the skin of the animal.
This study should provide a rational basis for risk assessment to the sensitizing potential of the test item in man.
Study Design
For this purpose Induction was performed in two stages. At first the test material was intradermally injected with and without Freund's complete adjuvant. Then, after one week, the test material was topically applied under occlusive patch conditions for 48 hours. The challenge was performed two weeks later by topical application. The patches were then applied for 24 hours.
Results
induction phase:
The injection sites were swollen and red. Later necrosis and scabs were observed. Similar findings were seen with liquid paraffin. After removal of the patches redness and scales were observed at the topical application sites
after challenge:
No irritation was observed in the test group. 24 h after challenge with the test item, a barely perceptible erythema was observed in two female animals and considered as not positive. At the 48 h reading the challenge sites in two female animals were covered with scales. These reactions were evaluated as a positive skin reaction.
The total positive reaction was 5%.
Conclusion
The test material was not a skin sensitiser under the test conditions of this study.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The available data on skin sensitization do not meet the criteria for classification according to Regulation (EC) 1272/2008.
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