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EC number: 215-397-8 | CAS number: 1325-54-8 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 40215.
- 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:
- 1995
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- Directive 92/69 EEC B6
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Species:
- guinea pig
- Strain:
- Himalayan
- Sex:
- male
- Details on test animals and environmental conditions:
TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd. Wölferstrasse 4, 4414 Füllinsdorf/Switzerland
- Age at study initiation:5-8 weeks
- Weight at study initiation: Control and Test Group: 341-489 g. Pretest 317-435g
- Housing: Individually
- Diet (e.g. ad libitum): pelleted standard Kliba 342, Batch no 68/95 guinea pig breeding/maintenance diet, ad libitum
- Water (e.g. ad libitum): Community tap water from F$üllinsdorf, ad libitum. Once weekly additional supply of ascorbic acid (1g/l) via the drinking water.
- Acclimation period:One week for the control and test group under test conditions after health examination. No acclimatization for the animals of the pretest. Only animals without any visible signs of illness were used for the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23°C
- Humidity (%): 48-60%
- Air changes (per hr):10-15
- Photoperiod (hrs dark / hrs light): 12-hour lighs, 12 hour dark cyle- Route:
- intradermal and epicutaneous
- Vehicle:
- physiological saline
- Concentration / amount:
- First induction:
Test:
1- FCA: Phys. saline 1:1
2- 5% Bi-distilled water
3- 5% FCA: Phys. saline 1:1
Control:
1- FCA: Phys.saline 1:1
2- Bi-distilled water
3- FCA:Ph. sal. 1:1/bi-ditilled water
Second induction
Bi-distilled water 25%
Challenge:
Bi-distilled water 15% - Route:
- epicutaneous, semiocclusive
- Vehicle:
- physiological saline
- Concentration / amount:
- First induction:
Test:
1- FCA: Phys. saline 1:1
2- 5% Bi-distilled water
3- 5% FCA: Phys. saline 1:1
Control:
1- FCA: Phys.saline 1:1
2- Bi-distilled water
3- FCA:Ph. sal. 1:1/bi-ditilled water
Second induction
Bi-distilled water 25%
Challenge:
Bi-distilled water 15% - No. of animals per dose:
- Control group: 10 males in control group
Test group: 20 males in test group
Intradermal Pretest: 2 males.
Epidermal pretest: 4 males
I - Details on study design:
- RANGE FINDING TESTS:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures:three pairs of intradermal injections
- Exposure period: 7 days
- Test groups:
1) 1:1 (v/v) mixture of Freund's Complete Adjuvant and
physiological saline.
2) The test article, diluted to 5% with bi-distilled water,
3) The test article diluted to 5% by emulsion in a 1:1
(v/v) mixture of Freund's Complete Adjuvant and
physiological saline.
- Control group:
1)1:1 (v/v) mixture of Freund's Complete Adjuvant and
physiological saline.
2) Bi-distilled water
3) 1:1 (w/w) mixture of bi-distilled water in a 1:1 (v/v)
mixture of Freund's Complete Adjuvant and physiological
saline.
- Site: dorsal skin from the scapular region (approximaterly 6 X 8 cm) was clipped free of hair.
- Frequency of applications: 1 week
- Duration: 24h and 48h.
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge:
- Exposure period: 24h -48h
- Site:Hair was clipped and shaved from a 5 x 5 cm area on the left and right flank of each guinea-pig just prior to the application. Two patches ( 2 x 2 cm) of filter paper were saturated with the highest non-irritating concentration of 15% (left flank) and the vehicle only (bi-distilled water, applied to he right flank) using the same method as for the epidermal application.
- Concentrations:
- Evaluation (hr after challenge): The test animals were considered to show no evidence of contact hypersensitivity
if the dermal reactions to the challenge application were identical to or less
marked and/or persistent than the reactions observed in the control animals. - Positive control substance(s):
- yes
- Remarks:
- 4-aminobenzoic acid ethyl ester and 2- mercaptobenyothiazol
- Positive control results:
- For validation of sensitivity of the Maximization-Test of B. Magnusson and A.M. Kligman (1969) as well as the sensitivity of the test system used, a known sensitizer (2-MERCAPTOBENZOTHIAZOL) was selected as a positive control.
In this study 95% and 90% of the animals of the test group were observed with positive skin reactions at the 24- and 48-hour reading respectively after treatment with a non-irritant test substance concentration of 5% in peanut oil. No skin reactions were observed in the control group. The results obtained with the test article at 10% in peanut oil were not taken into consideration since the both control group were observed with erythematous reactions.
For validation of sensitivity of the Maximization-Test of B. Magnusson and A.M. Kligman (1969) as well as the sensitivity of the test system used, a known mild sensitizer was selected as a positive control (4-AMIN0BENZ0IC ACID ETHYL ESTER). In this study 30% and 35% of the animals of the test group were observed with positive skin reactions after treatment with a non-irritant test substance concentration of 30% in mineral oil. No skin reactions were observed in the control group.
The response of at least 30% positive animals is considered positive "R43" following the "Commission Directive 93/21/EEC, April 27, 1993 adapting to technical progress for the 18th time Council Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances".
The test article 2-MERCAPTO-BENZOTHIAZOL at concentration of 5% in peanut oil is considered according to the rating of allergenicity by Magnusson and Kligman as an extreme sensitizer.
The test article 4-AMINOBENZOIC ACID ETHYL ESTER at concentration of 30% in mineral oil is considered according to the rating of allergenicity by Magnusson and Kligman as a moderate sensitizer. - Reading:
- other: Intradermal induction
- Hours after challenge:
- 0
- Group:
- test chemical
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- Evolution of local symptoms
- Remarks on result:
- other: Reading: other: Intradermal induction. . Hours after challenge: 0.0. Group: test group. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: Evolution of local symptoms.
- Reading:
- other: intrademal induction
- Hours after challenge:
- 0
- Group:
- negative control
- Clinical observations:
- Evolution of local symptoms
- Remarks on result:
- other: Reading: other: intrademal induction. . Hours after challenge: 0.0. Group: negative control. Clinical observations: Evolution of local symptoms.
- Reading:
- other: epidermal induction
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25% in bi-distilled water
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- Skin effects (erythema and edema). Due to orange-red discoloration produced by the test substance a possible erythema reaction could not be determined.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: other: epidermal induction. . Hours after challenge: 24.0. Group: test group. Dose level: 25% in bi-distilled water. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: Skin effects (erythema and edema). Due to orange-red discoloration produced by the test substance a possible erythema reaction could not be determined..
- Reading:
- other: epidermal induction
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25% in bi-distilled water
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- Skin effects (erythema and edema). Due to orange-red discoloration produced by the test substance a possible erythema reaction could not be determined.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: other: epidermal induction. . Hours after challenge: 48.0. Group: test group. Dose level: 25% in bi-distilled water. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: Skin effects (erythema and edema). Due to orange-red discoloration produced by the test substance a possible erythema reaction could not be determined..
- Reading:
- other: epidermal induction
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- vehicle, bi-distilled water
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Skin effects (erythema and edema)
- Remarks on result:
- other: Reading: other: epidermal induction. . Hours after challenge: 24.0. Group: negative control. Dose level: vehicle, bi-distilled water. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: Skin effects (erythema and edema).
- Reading:
- other: epidermal induction
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- vehicle, bi-distilled water
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Skin effects (erythema and edema)
- Remarks on result:
- other: Reading: other: epidermal induction. . Hours after challenge: 48.0. Group: negative control. Dose level: vehicle, bi-distilled water. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: Skin effects (erythema and edema).
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 15% in bi-distilled water.
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- Skin effects (erythema and edema)
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 15% in bi-distilled water.. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: Skin effects (erythema and edema).
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- vehicle, bi-distilled water
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- Skin effects (erythemand edema)
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: vehicle, bi-distilled water. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: Skin effects (erythemand edema).
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 15% in bi-distilled water.
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- Skin effects (erythema and edema)
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 15% in bi-distilled water.. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: Skin effects (erythema and edema).
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- vehicle, bi-distilled water
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- Skin effects (erythema and edema)
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: vehicle, bi-distilled water. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: Skin effects (erythema and edema).
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- vehicle, bi-distilled water
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Skin effects (erythema and edema)
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: vehicle, bi-distilled water. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: Skin effects (erythema and edema).
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- vehicle, bi-distilled water
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- Skin effects (erythema and edema)
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: vehicle, bi-distilled water. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: Skin effects (erythema and edema).
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 15% in bi-distilled water
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Skin effects (erythem and edema)
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 15% in bi-distilled water. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: Skin effects (erythem and edema).
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 15% in bi-distilled water
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Skin effects (erythema and edema)
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 15% in bi-distilled water. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: Skin effects (erythema and edema).
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In this study 0% of the animals of the test group were observed with positive skin reactions after treatment with a non-irritant test substance concentration of 15% in bi-distilled water. No skin reactions were observed in the control group.
The response of at least 30% positive animals is considered positive "R43" may cause sensitizer by skin contact following the "Commission Directive 93/21/EEC,April 27, 1993 adapting to technical progress for the 18th time Council Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances".
Therefore the test article at concentration of 15% in bi-distilled water is considered to be a non-sensitizer when described under the test conditions.
According to the rating of allergenicity by Magnusson and Kligman the test article is a non-sensitizer. - Executive summary:
To assess the allergenic potential of the substance in albino guinea pigs the Maximization-Test of B. Magnusson and A.M.Kligman (1969) was used. Ten males were used as control group and 20 males were used as test group.
Before the test procedure a pretest was performed in order to identify a maximally tolerated concentration of the test article suitable for the induction phase of the main study. In addition, a suitable non-irritant concentration of the test article, by the topical route of administration, was identified for the challenge application.
The pretest was performed with intradermal (0.1 ml/site, at concentrations of 1,3 and 5% of the test article in bi-distilled water) and epidermal induction (5, 10, 15 and 25% of test material in bi-distilled water).
The results of the pretest were:
- For intradermal induction application a 5% test article dilution in bi-distilled water was selected.
- For the epidermal induction and challenge procedure the test article at 25% in bi-distilled water was selected for the induction application and that of a concentration of 15% was selected for the challenge application.
In this study 0% of the animals of the test group were observed with positive skin reactions after treatment with a non-irritant test substance concentration of 1556 in bi-distilled water. No skin reactions were observed in the control group. According to the rating of allergenicity by Magnusson and Kligman the test article is considered a non-sensitizer.
Reference
VIABILITY / MORTALITY / MACROSCOPIC FINDINGS: As there were no deaths during the course of the treatment period no necropsies were performed.
CLINICAL SIGNS, SYSTEMIC: No symptoms of systemic toxicity were observed in the animals.
BODY WEIGHTS: Two out of 10 animals of the control group (nos. 325, 330) and one out of 20 animals of the test group (no. 346) incidentally lost weight during the acclimatization period. No weight loss was observed during treatment period.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
There are two studies available for this endpoint. Both of them were performed according to Guideline OECD 406 and were GLP compliant.
In the study of Hagemann (1993) the test material used for testing was "roh trocken" meaning "crude". The sample tested had a content of 91% of active substance and inside the report it is defined that purity is 27%. In a more recent study done by Arcelin (1995) the test material is described as "gereignit" meaning "purified". The composition of the tested sample is not known. When purified, it is assumed that the purity of the sample will be higher than the one used in Hagemann (1993) test.
Under the test conditions of Arcelin (1995), EC 215-397-8 at concentrations of 15% in bi-distilled water is considered to be a non-sensitizer. Similar results are obtained with testing conditions of Hagemann (1993) at concentration 20% in vaseline.
There is also one study done with humans in 1972, Shelansky (1972). This is a human repeated insult patch test and the tested material gave a negative result on sensitisation when tested at 4% in 200 individuals covering a wide range of ages. The human patch test does not give any information concerning classification.
The substance to register has a higher purity than the test item used in the Hagemann’s study (27%) and therefore closer to the test substance used in Arcelin’s study. It can be concluded that the substance is not skin sensitizer.
Justification for selection of skin sensitisation endpoint:
The study is a GLP compliant and has Klimisch score 1
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
This endpoint is not an information requirement of Annex IX of REACH Regulation.
Justification for classification or non-classification
Based on the above stated assessments of the skin sensitisation potential, the substance is classified as non-sensitising according to Directive 67/548/EEC and according to CLP (Regulation (EC) No 1272/2008 of the European Parliament and of the Council) as implementation of UN-GHS in the EU.
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