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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 473-730-4 | CAS number: 928768-73-4
- 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
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:
- 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: according to EC Directive 92/69/EEC and Regulation EC/440/2008 guideline methods under GLP conditions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Justification for selection of skin sensitisation endpoint: Two studies available. OECD 429 has not been selected since a LLNA may give fals positive results. See publication of Ball et al., 2011. Regul. Toxicol. Pharmacol. 60:389–400 Study done according to EC Directive 92/69/EEC and Regulation EC/440/2008 guideline methods under GLP conditions. Klimisch rating = 1.
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- Animals were received from Elm Hill Breeding Labs, Chelmsford, MA on 0111 1/06, 01/18/06 and 01/25/06.
Following an equilibration period of at least five days, eighteen healthy male and eighteen healthy female
Hartley Albino guinea pigs were randomly assigned to the treatment groups.
The animals were born on 12/21/05, 12/28/05 and 01/08/06. The pretest body weight range was 280 -
391 g for males and 262 - 344 g for females. The weight variation of the animals did not exceed + 20% of
the mean weight. The animals were identified by cage notation and a uniquely numbered metal eartag
and housed llcage in suspended wire mesh cages. Bedding was placed beneath the cages and changed
at least three timeslweek. Fresh PMI Guinea Pig Chow (Diet #5025) and water were available ad libitum.
The animal room, reserved exclusively for guinea pigs on acute tests, was temperature controlled, had a
12 hour lightldark cycle, and was kept clean and vermin free. - Route:
- intradermal
- Vehicle:
- corn oil
- Concentration / amount:
- The test article was used as received and prepared in corn oil, to the following five concentrations: 1, 10,
25, 50 and 75%. Three guinea pigs were dosed intradermally using a syringe and 23 gauge needle, with
0.1 ml of each of the following test article concentrations: 1, 10, 25 and 50%. Three other guinea pigs
were dosed topically with 0.1 ml of each of the following test article concentrations: 25, 50, 75 and 100%.
For the topical applications, 0.1 ml of the test article mixture was applied to 2 x 2 cm squares of
Whatman's #I filter paper which were applied to the skin. The patches, occluded with plastic and
fastened with non-irritating tape, remained in place for 24 hours. - Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- The test article was used as received and prepared in corn oil, to the following five concentrations: 1, 10,
25, 50 and 75%. Three guinea pigs were dosed intradermally using a syringe and 23 gauge needle, with
0.1 ml of each of the following test article concentrations: 1, 10, 25 and 50%. Three other guinea pigs
were dosed topically with 0.1 ml of each of the following test article concentrations: 25, 50, 75 and 100%.
For the topical applications, 0.1 ml of the test article mixture was applied to 2 x 2 cm squares of
Whatman's #I filter paper which were applied to the skin. The patches, occluded with plastic and
fastened with non-irritating tape, remained in place for 24 hours. - Details on study design:
- Test Animals
Animals were received from Elm Hill Breeding Labs, Chelmsford, MA on 0111 1/06, 01/18/06 and 01/25/06.
Following an equilibration period of at least five days, eighteen healthy male and eighteen healthy female
Hartley Albino guinea pigs were randomly assigned to the treatment groups.
The animals were born on 12/21/05, 12/28/05 and 01/08/06. The pretest body weight range was 280 -
391 g for males and 262 - 344 g for females. The weight variation of the animals did not exceed + 20% of
the mean weight. The animals were identified by cage notation and a uniquely numbered metal eartag
and housed llcage in suspended wire mesh cages. Bedding was placed beneath the cages and changed
at least three timeslweek. Fresh PMI Guinea Pig Chow (Diet #5025) and water were available ad libitum.
The animal room, reserved exclusively for guinea pigs on acute tests, was temperature controlled, had a
12 hour lightldark cycle, and was kept clean and vermin free.
Site Preparation
The day prior to the screen, lnduction A, lnduction B, or Challenge, the sites (back or sides) were clipped
free of hair with an electric clipper. Upon examination prior to the screen or lnduction A, animals with skin
irregularities or irritation were eliminated from the study.
Preliminary Screen
The preliminary screen was conducted to determine the concentration for intradermal injection which was
not necrotic, ulcerogenic or toxic. For the topical application, the concentration of the test article must be
well tolerated systemically and produce no more than mild to moderate skin irritation. Based on the
results of the preliminary screen, the intradermal concentration selected was 1%, and the topical
concentration was 100%.
The test article was used as received and prepared in corn oil, to the following five concentrations: 1, 10,
25, 50 and 75%. Three guinea pigs were dosed intradermally using a syringe and 23 gauge needle, with
0.1 ml of each of the following test article concentrations: 1, 10, 25 and 50%. Three other guinea pigs
were dosed topically with 0.1 ml of each of the following test article concentrations: 25, 50, 75 and 100%.
For the topical applications, 0.1 ml of the test article mixture was applied to 2 x 2 cm squares of
Whatman's #I filter paper which were applied to the skin. The patches, occluded with plastic and
fastened with non-irritating tape, remained in place for 24 hours.
Sensitization Study
There are two stages to the maximization test. The first stage is the induction and consists of intradermal
injections followed in 7 days by a topical application of the test article. The second stage is the challenge
which consists of a topical application performed 14 days following completion of the induction phase.
Dosing
One group of tenisex served as the test article group. One group of fivelsex served as the control group.
lnduction A: Six intradermal injections, using a 23 gauge needle, were made on the 4 x 6 cm prepared
site as follows:
Sites "b" received 0. 1 ml of a 1 % concentration of the test article mixture on both sjdes or 100% corn
oil on both sides
Sites "c" received 0.1 ml of a mixture containing equal parts of 50% FCA and a 1 % concentration of
the test article on both sides or equal parts of 50% FCA and corn oil on both sides
lnduction 6: Because a 100% concentration of the test article did not produce irritation in the preliminary
screen, the animals were pretreated with 0.5 ml of a 10% mixture of sodium lauryl sulfate approximately
24 hours prior to induction B and the sites remained unoccluded. At least 2 hours prior to lnduction B, any
residual sodium lauryl sulfate solution was removed with distilled water. Seven days after lnduction A, the
guinea pigs in the test article group were dosed topically (at 'IND B', on the chart above) using 2 x 4 cm
patches of Whatman's #I filter paper, saturated with 0.2 ml of the 100% concentration. The patches,
occluded with plastic and fastened with adhesive tape, remained in place for 48 hours. The guinea pigs in
the control group were dosed in the same manner with the vehicle control.
Challenqe: Fourteen days after lnduction B, the test and control animals were challenged topically (at 'test
art.' on the chart above) using 2 x 2 cm patches of Whatman's #1 filter paper, saturated with 0.1 ml of a
50% concentration of the test substance. The vehicle was applied topically (at 'veh' on the chart above).
All sites were occluded with plastic and secured with non-irritating tape for 24 hours
Type and Frequency of Observations
Skin reactions:
Induction A: The treated site of each animal was examined and scored for dermal reactions at 24
and 48 hours after injection.
Induction B: The treated site of each animal was examined and scored at 48 hours after application
of the saturated patch.
Challenge: The challenge sites, both test article and control, of each animal were examined and
scored at 24 and 48 hours after patch removal.
Erythema was evaluated using the following numerical scale. Additional signs were described
No visible change
Discrete or patchy erythema
Moderate and confluent erythema
Intense erythema and swelling
Clinical signs: Animals were observed once daily for mortality and toxicity
Body Weights: Body weights were recorded pretest and at termination.
Sacrifice: At study termination, all survivors were humanely sacrificed using C02.
Analysis of Data
A score of 1 or greater at challenge is considered to be a positive reaction. Sensitization potential is
determined according to the following table:
Sensitization Grade Sensitization Classification
Rate (%)
0-8 I Weak
9-28 II Mild
29-64 Ill Moderate
65-80 IV Strong
81-100 V Extreme - Challenge controls:
- Challenge: The challenge sites, both test article and control, of each animal were examined and
scored at 24 and 48 hours after patch removal. - Positive control substance(s):
- no
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50 % of Test Substance
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Clinical observations:
- None
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 % of Test Substance
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 25 % 2-Mercaptobenzothiazole
- No. with + reactions:
- 6
- Total no. in group:
- 20
- Clinical observations:
- None
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 25 % 2-Mercaptobenzothiazole
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Clinical observations:
- None
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50 % corn oil
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50 % corn oil
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information
- Conclusions:
- According to the GHS purple book, at least a 30% response in a guinea pig Maximization Test (OECD 406) is needed to consider a material to be a dermal sensitizer. The test substance is a non-sensitizer since the response was only 10%.
- Executive summary:
The test substance is a non-sensitizer since the response was only 10%.
Reference
Dermal Observations (Post Induction A) | |||||||||||||||
FCA | Test Substance | Test Substance (TS) | |||||||||||||
0.1 ml of 50% conc. In destilled water | 0.1 ml of 1% conc. Mixture | 0.1 ml of equal parts 50% FCA & 1% TS | |||||||||||||
Site a - Left | Site a - Right | Site b - Left | Site b - Right | Site c - Left | Site c - Right | ||||||||||
Animal# | Sex | 24 hours | 48 hours | 24 hours | 48 hours | 24 hours | 48 hours | 24 hours | 48 hours | 24 hours | 48 hours | 24 hours | 48 hours | ||
C9906 | M | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 0 | 2 | 1 | ||
C9907 | M | 2 | 1 | 2 | 1 | 1 | 1 | 1 | 1 | 0 | 0 | 1 | 1 | ||
C9908 | M | 1 | 1 | 1 | 1 | 1 | 0 | 1 | 0 | 1 | 1 | 1 | 1 | ||
C9909 | M | 2 | 2 | 2 | 2 | 1 | 1 | 1 | 1 | 2 | 2 | 2 | 2 | ||
C9910 | M | 1 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 1 | ||
C9911 | M | 1 | 2 | 1 | 2 | 1 | 1 | 1 | 1 | 1 | 2 | 1 | 2 | ||
C9912 | M | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 1 | ||
C9913 | M | 1 | 1 | 1 | 1 | 1 | 0 | 1 | 0 | 1 | 1 | 0 | 1 | ||
C9914 | M | 1 | 1 | 1 | 1 | 1 | 0 | 1 | 0 | 0 | 0 | 1 | 1 | ||
C9915 | M | 2 | 2 | 2 | 2 | 1 | 1 | 1 | 0 | 1 | 1 | 1 | 1 | ||
C9916 | F | 1 | 2 | 1 | 2 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | ||
C9917 | F | 2 | 1 | 2 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
C9918 | F | 1 | 2 | 1 | 2 | 1 | 1 | 0 | 1 | 1 | 0 | 1 | 1 | ||
C9919 | F | 1 | 1 | 1 | 1 | 1 | 0 | 1 | 1 | 1 | 1 | 1 | 1 | ||
C9920 | F | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | ||
C9921 | F | 1 | 1 | 1 | 1 | 1 | 1 | 0 | 0 | 1 | 0 | 1 | 1 | ||
C9922 | F | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 2 | 1 | 1 | 1 | ||
C9923 | F | 1 | 0 | 1 | 1 | 1 | 0 | 2 | 0 | 2 | 1 | 2 | 0 | ||
C9924 | F | 1 | 1 | 1 | 1 | 0 | 0 | 1 | 0 | 1 | 1 | 1 | 1 | ||
C9925 | F | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 1 | 0 | 1 | 1 | ||
Vehicle Control; Corm Oil, Dermal Observations (Post Induction A) | |||||||||||||||
FCA | Test Substance | Test Substance (TS) | |||||||||||||
0.1 ml of 50% conc. In destilled water | 0.1 ml of 1% conc. Mixture | 0.1 ml of equal parts 50% FCA & 1% TS | |||||||||||||
Site a - Left | Site a - Right | Site b - Left | Site b - Right | Site c - Left | Site c - Right | ||||||||||
Animal# | Sex | 24 hours | 48 hours | 24 hours | 48 hours | 24 hours | 48 hours | 24 hours | 48 hours | 24 hours | 48 hours | 24 hours | 48 hours | ||
C9926 | M | 2 | 1 | 2 | 1 | 1 | 0 | 1 | 0 | 1 | 1 | 0 | 1 | ||
C9927 | M | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | ||
C9928 | M | 1 | 1 | 1 | 1 | 0 | 0 | 0 | 1 | 1 | 1 | 1 | 1 | ||
C9929 | M | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
C9930 | M | 1 | 0 | 1 | 1 | 1 | 0 | 1 | 0 | 1 | 0 | 2 | 1 | ||
C9931 | F | 2 | 1 | 2 | 1 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 1 | ||
C9932 | F | 1 | 0 | 0 | 1 | 1 | 0 | 1 | 0 | 1 | 0 | 1 | 1 | ||
C9933 | F | 1 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 1 | ||
C9934 | F | 2 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | ||
C9935 | F | 2 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | ||
Vehicle Control; Corm Oil, Dermal Observations (Post Induction B) | |||||||||||||||
Induction B (0.2 ml) | Challenge (0.1 ml) | ||||||||||||||
100% corn oil | Left Flank, 50% conc. of test substance | Right Flank, 100% corn oil | |||||||||||||
Animal# | Sex | 48 hours | 24 hours | 48 hours | 24 hours | 48 hours | |||||||||
C9926 | M | 2 | 0 | 0 | 0 | 0 | |||||||||
C9927 | M | 1 | 0 | 0 | 0 | 0 | |||||||||
C9928 | M | 0 | 0 | 0 | 0 | 0 | |||||||||
C9929 | M | 3 | 0 | 0 | 0 | 0 | |||||||||
C9930 | M | 1 | 0 | 0 | 0 | 0 | |||||||||
C9931 | F | 3 | 0 | 0 | 0 | 0 | |||||||||
C9932 | F | 1 | 0 | 0 | 0 | 0 | |||||||||
C9933 | F | 2 | 0 | 0 | 0 | 0 | |||||||||
C9934 | F | 1 | 0 | 0 | 0 | 0 | |||||||||
C9935 | F | 0 | 0 | 0 | 0 | 0 | |||||||||
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
“LLNA often shows false positive for nonionic surfactants and is not recommended for these chemicals. See publication of Ball et al., 2011. Regul. Toxicol. Pharmacol. 60:389–400”
Migrated from Short description of key information:
The test substance was identified not to be a skin sensitizer.
Justification for selection of skin sensitisation endpoint:
Two studies available. OECD 429 has not been selected since a LLNA may give fals positive results. See publication of Ball et al., 2011. Regul. Toxicol. Pharmacol. 60:389–400
Study done according to EC Directive 92/69/EEC and Regulation EC/440/2008 guideline methods under GLP conditions. Klimisch rating = 1.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
According to the UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS) Part 3 Chapter 3.4 this substance is not causing concern to be sensitizing.
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.