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EC number: 468-890-7 | 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2005-01-26 to 2005-05-09
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted 17 July 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- 30 September 1996
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- OECD Guideline 406 "Skin Sensitisation" method (GPMT) was performed before the LLNA was set as preferred test method. Moreover, the chemical structure of the substance, a maleic acid derivative, may result in a false-positive result in the LLNA as described by Kreiling et al (2008) Food Chem Toxicol, 46, 1896-1904.
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Strain: HsdPoc:DH
- Source: Harlan Winkelmann GmbH, Bochum, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: approx. 7 weeks
- Weight at study initiation: 348g (mean)
- Housing: The guinea pigs were housed in a 10 m^2 room. Five guinea pigs were housed in type GM/5 (EBECO) Makrolon cages with a shelter and placed on mobile racks. The animals were kept on conventional softwood granulate as the bedding. The cages had been machine cleaned before the start of the study. The bedding was changed two times a week.
- Diet: ad libitum (Provimi Kliba 3418.0)
- Water: ad libitum (Community tap water)
- Acclimation period: at least 7 days
- Indication of any skin lesions:
ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 22°C
- Humidity: 35 - 64% (transiently outside the target range of 45 - 75%. This minor and short deviation did not influence the integrity of the study).
- Photoperiod: 12 hrs dark / 12 hrs light
- IN-LIFE DATES: From: 2005-02-15 To: 2005-03-11
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- paraffin oil
- Remarks:
- with and without Freund's complete adjuvant
- Concentration / amount:
- 5g/L
- Day(s)/duration:
- on day 1
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- polyethylene glycol
- Remarks:
- PEG 400
- Concentration / amount:
- 100g/L
- Day(s)/duration:
- 48 hours (applied 1 week after intradermal injection)
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- polyethylene glycol
- Remarks:
- PEG 400
- Concentration / amount:
- 50 g/L
- Day(s)/duration:
- 24 hours (applied 2 weeks after topical induction)
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Total: 15 females
Control group: 5 females
Test group 10 females - Details on study design:
- MAIN STUDY
A1. INDUCTION EXPOSURE (intradermal injection)
Group 1: Polyethylene glycol 400
cranial: 0.1 ml Freund's complete adjuvant + sodium chloride solution
medial: 0.1 ml Liquid paraffin
caudal: 0.1 ml Freund's complete adjuvant + sodium chloride solution
Group 2: test material (5 g/L in PEG 400)
cranial: 0.1 ml Freund's complete adjuvant + sodium chloride solution
medial: 0.1 ml test material (5 g/L liquid paraffin)
caudal: 0.1 ml Freund's complete adjuvant with test material + sodium chloride solution (5 g test material/L preparation)
A2. INDUCTION EXPOSURE (topical application)
Group 1: Polyethylene glycol 400
Group 2: test material (100 g/L polyethylene glycol 400)
- Frequency of applications: single
- Duration: 48 h, occlusive
- Concentrations: 100 g/L
B. CHALLENGE EXPOSURE
- No. of exposures: single topical application
- Day(s) of challenge: 1d
- Exposure period: 2 weeks after topical application
Group 1: Topical induction: PEG 400
Challenge: PEG 400
Primary irritation: test material (50 g/L in PEG 400)
Group 2: Topical induction: test material (100 g/L in PEG 400)
Challenge: test material (50 g/L in PEG 400)
Primary irritation: PEG 400
Clinical Investigations.
During the induction phase, the guinea pigs were examined on days 2, 3, 7, 11, 12, 15, and 22 of the experimental part for local skin reactions, and the results were documented.
The behavior and general condition of all animals were monitored daily.
The challenge sites were investigated for reactions 48 hours after start of the challenge. Further inspections followed 72 hours after start of the challenge, to detect weak or slowly developing reactions.
After challenge skin changes at the application sites were evaluated according to the following MAGNUSSON and KLIGMAN scheme.
-----------------------------------------------------------------------
Reaction type Scores Definition
-----------------------------------------------------------------------
Negative reaction 0 no reaction
Positive reaction 1 scattered mild redness
2 moderate and diffuse redness
3 intense redness and swelling
-----------------------------------------------------------------------
Following the grading according to the EEC Directive 2001 /59/EEC, a result in an adjuvant method is considered positive if 30% or more of the test animals showed positive reactions.
Body weight
The body weight of the guinea pigs was determined prior to the start of the experimental part (day 1), on experimental days 8, 15, 22, and at the end of the experimental part. - Positive control substance(s):
- yes
- Remarks:
- The validity of the test is periodically tested using Hexalcinnamaldehyde as the positive control.
Results and discussion
- Positive control results:
- The GPMT test with alpha-Hexalcinnamaldehyde (Challenge: 25 g/L) resulted in 70% positive reactions (7/10 animals) and, thus, confirmed the validity of the test performed.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50 g/L
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no signs of toxicity
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 50 g/L
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no signs of toxicity
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 g/L
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- no signs of toxicity
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 50 g/L
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no signs of toxicity
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 25 g/L
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Clinical observations:
- No clinical signs
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- positive control
- Dose level:
- 25 g/L
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- After challenge, one animal showed positive reaction in the test material treated skin sites at the first reading (48 hours) but not in the second reading (72 hours). This results in 10 % positive reactions at challenge. Therefore, the test material is not considered as a sensitizer for the skin. According to the EEC Directive, the test material has not to be classified as a sensitizer.
- Executive summary:
Purpose
The purpose of this GPMT assay was to identify the contact allergenic potential of the test item. This study should provide a rational basis for risk assessment to the sensitising potential of the test item in man.
Study Design
The test item was evaluated for skin sensitizing properties in the guinea pig maximization test according to MAGNUSSON and KLIGMAN (1969).
5 Female guinea pigs in the negative control group (group 1) treated with the vehicles (liquid paraffin and polyethylene glycol 400) and 10 females in the test material group (group 2) were investigated.
Induction included intradermal injection of test material preparation in liquid paraffin (5 g/L with and without Freund's complete adjuvant) on experimental day 1, and topical application for 48 hours of test material preparation in polyethylene glycol 400 (100 g/L) on experimental day 8.
Challenge was performed two weeks after topical induction by topical application for 24 hours of the test material preparation in polyethylene glycol 400 (50 g/L) and readings were taken at 48 hours and 72 hours.
Results
After intradermal injection, the common signs of irritation after injection of Freund's complete adjuvant were observed. The injection sites were swollen and red, later on, scabs developed.
After challenge with polyethylene glycol 400, no erythema or edema were observed at the readings.
A single treatment was performed with the test substance (50 g/L polyethylene glycol 400) to exclude primary irritation of the test material concentration. No positive reactions were observed in the treated areas at any reading.
After challenge with the test substance (50 g/L preparation in polyethylene glycol 400) a single positive skin reaction was observed in one animal at the first reading. Thus resulting in 10 % positive reactions after challenge.
After challenge, no positive reactions were observed in the areas treated with polyethylene glycol 400 alone at any reading.
The clinical behavior of the guinea pigs was normal during the experimental part. All animals survived the experimental part.
The body weight development corresponded to that of the animals of the vehicle group.Reactions after challange:
Induction
withChallenge
withPositive/animals
(48 h after challange)Positive/animals
(72 h after challange)Positive/animals
(overall)test substance test substance 1/10 0/10 1/10
Conclusion
After challenge, one animal showed positive reaction in the test material treated skin sites at the first reading but not in the second reading. This results in 10 % positive reactions at challenge. Therefore, the test material is not considered as a sensitizer for the skin. According to the EEC Directive, the test material has not to be classified as a sensitizer.
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