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EC number: 201-579-4 | CAS number: 85-00-7
- 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 sensitisation: sensitising, male/female, Guinea pig, OECD 406, Rattray 1990
- Respiratory sensitisation: not expected to be of concern for respiratory sensitisation
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:
- Aug 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Version / remarks:
- 2003
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- 1996
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Currently no LLNA study is available for assessment. The GPMT (depending on the test) test has been carried out as an animal test to predict human sensitisation for over a decade and is recommended by international test guidelines such as OECD.”
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Remarks:
- Alpk
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 5 - 7 weeks (males); 7 - 10 weeks (females)
- Weight at study initiation: 278 - 418 g (males); 303 - 413 g (females)
- Housing: Individually in suspended cages (37 cm x 32 cm x 20 cm)
- Diet: Guinea Pig Diet ad libitum
- Water: Water ad libitum
- Acclimation period: Minimum of 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 ± 2
- Humidity (%): 50 ±10
- Air changes (per hr): 20 - 30
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From Aug 1989 To: Aug 1989 - Route:
- intradermal
- Vehicle:
- other: deionised water
- Concentration / amount:
- Injection: 0.05 to 0.1 mL
Treatment: Freund’s complete adjuvant (FCA) plus deionised water in the ratio 1:1
Control: Freund’s complete adjuvant (FCA) plus deionised water in the ratio 1:1 - Day(s)/duration:
- Day 0: First injection of the three pairs of intradermal injections
- Route:
- intradermal
- Vehicle:
- other: deionised water
- Concentration / amount:
- IInjection: 0.05 to 0.1 mL
Treatment: 0.1 % (w/v) preparation of the test sample in deionised water
Control: deionised water - Day(s)/duration:
- Day 0: Second injection of the three pairs of intradermal injections
- Adequacy of induction:
- other: Well tolerated locally and systemically
- Route:
- intradermal
- Vehicle:
- other: deionised water
- Concentration / amount:
- Injection: 0.05 mL to 0.1 mL
Treatment: 0.1 % (w/v) preparation of the test sample in a 1:1 preparation of FCA plus deionised water
Control: a 1:1 preparation of FCA plus deionised water - Day(s)/duration:
- Day 0: Third injection of the three pairs of intradermal injections
- Adequacy of induction:
- other: Well tolerated locally and systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: deionised water
- Concentration / amount:
- Volume/area: 0.2 - 0.3 mL/4x2 cm over the site of injection
Treatment: undiluted test substance, occlusive - Day(s)/duration:
- Day 7: all tested animals for 48 hours
- Adequacy of induction:
- highest technically applicable concentration used
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- Volume/area: 0.2 - 0.3 mL/4x2 cm over the site of injection
Treatment: nothing applied - Day(s)/duration:
- Day 7: all contol animals
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: deionised water
- Concentration / amount:
- Volume/area: 0.05 - 0.1 mL / 1 cm x 1.5-2.0 cm area on the shorn flanks of each guinea pig.
Treatment: (1) undiluted test substance, (2) 10 % (w/v) preparation of test substance in deionised water, (3 and 4) deionised water (x2) - Day(s)/duration:
- Day 21: occlusive dressing for 24 h
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Main study: 20 test and 20 control females
- Details on study design:
- ANIMAL ASSIGNMENT AND TREATMENT:
The sensitisation potential of test substance was assessed using a method based on the maximisation test. Two main procedures were involved; (a) the induction of an immune response; (b) a challenge of that response.
POSITIVE CONTROLS:
A positive control study was conducted using essentially the same methodology and using formaldehyde as the test substance. The method used an intradermal induction of a 0.3 % w/v preparation in deionised water and 30 % w/v preparations in deionised water for the topical induction and challenge phase. - Challenge controls:
- 0.05 - 0.1 mL of deionised water
- Positive control substance(s):
- yes
- Remarks:
- formaldehyde was used as the test substance
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- undiluted test substance
- No. with + reactions:
- 4
- Total no. in group:
- 16
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10 % w/v preparation
- No. with + reactions:
- 1
- Total no. in group:
- 16
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0 (deionised water)
- No. with + reactions:
- 0
- Total no. in group:
- 16
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- undiluted test substance
- No. with + reactions:
- 0
- Total no. in group:
- 17
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10 % w/v preparation
- No. with + reactions:
- 0
- Total no. in group:
- 17
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0 (deionised water)
- No. with + reactions:
- 0
- Total no. in group:
- 17
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 30 % w/v aqueous dilution
- No. with + reactions:
- 17
- Total no. in group:
- 18
- Clinical observations:
- mild redness or moderate diffuse redness
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- undiluted test substance
- No. with + reactions:
- 2
- Total no. in group:
- 16
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10 % w/v preparation
- No. with + reactions:
- 0
- Total no. in group:
- 16
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 16
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 30 % w/v aqueous dilution
- No. with + reactions:
- 17
- Total no. in group:
- 18
- Clinical observations:
- scattered mild redness or moderate diffuse redness
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- Challenge of previously induced guinea pigs with undiluted test substance elicited a moderate sensitisation response and challenge with a 10 % w/v preparation elicited a weak sensitisation response.
- Executive summary:
The sensitisation potential of the test substance was assessed in accordance with OECD 406 and in compliance with GLP using the maximisation test of Magnusson and Kligman (1970). Groups of 20 test and 20 control young adult female Alpk:Dunkin Hartley guinea pigs were used for the main study. Two main procedures were involved; (a) the induction of an immune response; (b) a challenge of that response. For the main study, the concentrations used were 0.1 % (w/v) in deionised water for the induction intradermal injections, 100 % for the topical induction applications and 10 % (w/v) in deionised water and 100 % for the challenge applications. A positive control study was conducted using essentially the same methodology and using formaldehyde as the test substance. The method used an intradermal induction of a 0.3 % w/v preparation in deionised water and 30 % w/v preparations in deionised water for the topical induction and challenge phase.
Following challenge with the test substance in form of an aqueous technical concentrate, scattered mild redness was seen in 4/16 test and 0/17 control animals. The net response was calculated to be 31 %. Following challenge with a 10 % w/v preparation of the test sample in deionised water, scattered mild redness was seen in 1/16 test and 0/17 control animals. The net response was calculated to be 6 %. No erythematous reactions were seen in any test or control animal following challenge with deionised water. The net response was zero. In the positive control study following challenge with a 30 % w/v preparation of a 40 % w/v aqueous formaldehyde solution, scattered mild redness or moderate diffuse redness was seen in 17/18 test and 0/10 control animals. The net response was calculated to be 94 % and formaldehyde was considered to elicit an extreme sensitisation response in previously induced guinea pigs thereby confirming the sensitivity of the test.
Challenge of previously induced guinea pigs with undiluted test substance elicited a moderate sensitisation response and challenge with a 10 % w/v preparation elicited a weak sensitisation response.
Reference
MORTALITY / CLINICAL OBSERVATIONS
Two test and two control animals died, and a further test animal was killed in extremis, prior to challenge but these deaths were considered not to be treatment-related. The bandage used at challenge slipped on one test and one control animal and these animals were therefore excluded from analysis of the results.
BODY WEIGHTS:
There were no treatment-related effects on body weight during the study.
CHALLENGE REACTIONS AND DURATION:
Following challenge with the undiluted test sample, scattered mild redness was seen in 5/16 test and 0/17 control animals. The net response was calculated to be 31 %.
Following challenge with a 10 % w/v preparation of the test sample in deionised water, scattered mild redness was seen in 1/16 test and 0/17 control animals. The net response was calculated to be 6 %.
No erythematous reactions were seen in any animal, test or control, following challenge with deionised water. The net response was zero.
POSITIVE CONTROL:
In the positive control study following challenge with a 30 % w/v preparation of a 40 % w/v aqueous formaldehyde solution, scattered mild redness or moderate diffuse redness was seen in 17/18 test and 0/10 control animals. The net response was calculated to be 94 % and formaldehyde was considered to elicit an extreme sensitisation response in previously induced guinea pigs thereby confirming the sensitivity of the test.
Table 1: Maximisation test: Number of animals with signs of allergic skin reactions
Scored after: |
24 hours |
48 hours |
|
Test group |
undiluted test substance |
4/16 |
2/16 |
|
10 % w/v preparation |
1/16 |
0/16 |
|
deionised water |
0/16 |
0/16 |
|
deionised water |
0/16 |
0/16 |
Vehicle Control group |
undiluted test substance |
0/17 |
0/17 |
|
10 % w/v preparation |
0/17 |
0/17 |
|
deionised water |
0/17 |
0/17 |
|
deionised water |
0/17 |
0/17 |
Positive control (40 % w/v formaldehyde) |
30 % w/v aqueous dilution |
17/18 (0/10 control) |
17/18 (0/10 control) |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
The sensitisation potential of the test substance was assessed in accordance with OECD 406 and in compliance with GLP using the maximisation test of Magnusson and Kligman (1970). Groups of 20 test and 20 control young adult female Alpk:Dunkin Hartley guinea pigs were used for the main study. Two main procedures were involved; (a) the induction of an immune response; (b) a challenge of that response. For the main study, the concentrations used were 0.1 % (w/v) in deionised water for the induction intradermal injections, 100 % for the topical induction applications and 10 % (w/v) in deionised water and 100 % for the challenge applications. A positive control study was conducted using essentially the same methodology and using formaldehyde as the test substance. The method used an intradermal induction of a 0.3 % w/v preparation in deionised water and 30 % w/v preparations in deionised water for the topical induction and challenge phase.
Following challenge with the test substance in form of an aqueous technical concentrate, scattered mild redness was seen in 4/16 test and 0/17 control animals. The net response was calculated to be 31 %. Following challenge with a 10 % w/v preparation of the test sample in deionised water, scattered mild redness was seen in 1/16 test and 0/17 control animals. The net response was calculated to be 6 %. No erythematous reactions were seen in any test or control animal following challenge with deionised water. The net response was zero. In the positive control study following challenge with a 30 % w/v preparation of a 40 % w/v aqueous formaldehyde solution, scattered mild redness or moderate diffuse redness was seen in 17/18 test and 0/10 control animals. The net response was calculated to be 94 % and formaldehyde was considered to elicit an extreme sensitisation response in previously induced guinea pigs thereby confirming the sensitivity of the test.
Challenge of previously induced guinea pigs with undiluted test substance elicited a moderate sensitisation response and challenge with a 10 % w/v preparation elicited a weak sensitisation response. The test substance was classified as sensitising to the skin on the basis of these effects.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The test substance is not expected to be of concern for respiratory sensitisation. Following the recommended approach outlined in R.7.3.12.3, the test substance is not expected to be a respiratory sensitiser because the test substance is not di-isocyanate or protein. Furthermore, no structural warnings for respiratory sensitisation were found using the QSAR toolbox (v4.4).
Justification for classification or non-classification
Based on the available information the substance is classified as skin sensitiser category 1, H317: May cause an allergic skin reaction in accordance with EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008.
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