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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 434-430-9 | 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:
- From 2000-01-25 to 2000-10-11
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study predates LLNA REACH requirements
Test material
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: D. Hall, Newchurch, Staffs, UK
- Age at study initiation: 4 to 7 weeks
- Weight at study initiation: 351 - 428 g
- Housing: in groups of five suspended in metal cages with mesh floors
- Diet (e.g. ad libitum): A vitamin C enriched guinea-pig diet ad libitum ; hay was given thrice weekly
- Water (e.g. ad libitum): water ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.5 to 23.0°C
- Humidity (%): 39 to 63%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): a switch time to give 12 hours of artificial light (0600-1800 hours GMP) in each 24 hours period
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- vegetable oil
- Remarks:
- Commercial name: Alembicol D ( coconut oil supplied by Alembic products, Saltney, Chester, England)
- Concentration / amount:
- Concentration of test material and vehicle used at induction (intradermal and topical exposure):
Intradermal injection : 2.5% w/v* in Alembicol D Topical application : 60% w/v* in Alembicol D
*: highest to cause mild-to-moderate skin irritation based on preliminary assays
Concentration of test material and vehicle used for challenge: 20% ** and 10% w/v in Alembicol D
** highest non-irritant concentration based on preliminary assays
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- vegetable oil
- Remarks:
- Commercial name: Alembicol D ( coconut oil supplied by Alembic products, Saltney, Chester, England)
- Concentration / amount:
- Concentration of test material and vehicle used at induction (intradermal and topical exposure):
Intradermal injection : 2.5% w/v* in Alembicol D Topical application : 60% w/v* in Alembicol D
*: highest to cause mild-to-moderate skin irritation based on preliminary assays
Concentration of test material and vehicle used for challenge: 20% ** and 10% w/v in Alembicol D
** highest non-irritant concentration based on preliminary assays
- No. of animals per dose:
- - preliminary test: 4 treated animals
- main test: 5 control animals and 10 treated animals - Details on study design:
- RANGE FINDING TESTS: conducted to define the concentrations to be tested in the main study
-Intradermal exposure:
Hair over the scapulae was removed using electric clippers before treatment.
Intradermal administration of 0.1 ml of the test material (TM) at concentrations from 0.1 to 10% w/v in 2 animals.
Evaluation of the potential cutaneous reactions: 24 and 72 hours after injection
- Epicutaneous exposure:
Hair over the flanks were removed using electric clippers before treatment.
Each selected concentration applied to a filter paper patch measuring 4cm2 for 24 hours under occlusive dressing . 4 concentrations (60, 40, 20 and 10% w/v in Alembicol D) were tested in 4 animals.
Evaluation of the potential cutaneous reactions 24 and 48 hours after patch removal.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1 intradermal, 1 epicutaneous
- Exposure period: epicutaneous: 48 hours
-> TEST GROUPS:
Intradermal exposure
Three injections of 0.1 mL were injected into each side of the animal as follows:
. Freund's complete adjuvant (FCA) diluted to 50% with sterile water
. TM at 2.5 % w/v in vehicle
. TM at 2.5% w/v in a 50/50 (v/v) mixture of FCA and vehicle
Epicutaneous exposure
Application of 8 cm2 patch saturated with the undiluted TM to the scapular region and held in place for 48 hours using an occlusive dressing.
-> CONTROL GROUP:
Intradermal exposure
Three injections of 0.1 mL were injected into each side of the animal as follows:
. Freund's complete adjuvant (FCA) diluted to 50% with sterile water
. vehicle
. FCA diluted to 50% with vehicle
Epicutaneous exposure
Application of 8 cm2 patch saturated with the vehicle to the scapular region and held in place for 48 hours using an occlusive dressing.
- Site:
Intradermal exposure
6 injections in the clipped area (2x 4cm) in the scapular region
Epicutaneous exposure
2x 4cm in the interscapular area
- Frequency of applications:
One intradermal injection and one epicutaneous application on Day 8 on the same site.
- Duration:
Epicutaneous exposure: 48 hours
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 22
- Exposure period: 24 hours
-> TEST GROUPS:
Challenge: TM at 20% in the vehicle on an anterior site of the left flank and TM at 10% in the vehicle on the posterior site of the same flank (occlusive epicutaneous application)
-> CONTROL GROUPS:
Same treatment as test group
- Evaluation (hr after challenge): 24 , 48 hours after removal of the dressing according to the method of Draize.
- Challenge controls:
- Control animals received vehicle only.
- Positive control substance(s):
- yes
- Remarks:
- hexyl cinnamic aldehyde (HCA)
Results and discussion
- Positive control results:
- The positive control study was conducted between 15 december 1999 and 8 january 2000 using Hexyl cinnamic aldehyde (HCA).
Slight to well-defined dermal reactions were observed for nine of the ten animals comparing to the no dermal reactions in the control animals. Therefore
these nine test animals gave positive sensitization responses.
In this study, HCA produced evidence of skin sensitisation in nine of ten animals, thus confirming the sensitivity and reliability of the experimental
technique.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 20 %
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Clinical observations:
- Slight erythema
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Clinical observations:
- Slight erythema
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 20 %
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Clinical observations:
- Slight to well-defined erythema with or without slight oedema
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Clinical observations:
- Slight to well-defined erythema with or without slight oedema
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 20 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 20 %
- No. with + reactions:
- 1
- Total no. in group:
- 5
- Clinical observations:
- Dryness and sloughing of the epidermis
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
7.4.1.2: Dermal reactions observed after the challenge application:
Group |
Animal number |
E=Erythema O =Oedema |
Skin reaction (hour after removal of dressing) |
Results Positive (+) Negative (-) Inconclusive (±) |
|||
24 hours |
48 hours |
||||||
A |
P |
A |
P |
||||
Control group |
1990 |
E |
0 |
0 |
1* |
0 |
|
O |
0 |
0 |
0 |
0 |
|||
1991 |
E |
0 |
0 |
0 |
0 |
||
O |
0 |
0 |
0 |
0 |
|||
1992 |
E |
0 |
0 |
0 |
0 |
||
O |
0 |
0 |
0 |
0 |
|||
1993 |
E |
0 |
0 |
0 |
0 |
||
O |
0 |
0 |
0 |
0 |
|||
1994 |
E |
0 |
0 |
0 |
0 |
||
O |
0 |
0 |
0 |
0 |
|||
Treated group |
1995 |
E |
1 |
1 |
1 |
1 |
+ |
O |
0 |
0 |
1 |
1 |
|||
1996 |
E |
0 |
0 |
0 |
0 |
- |
|
O |
0 |
0 |
0 |
0 |
|||
1997 |
E |
1 |
1 |
2 |
2 |
+ |
|
O |
0 |
0 |
1 |
1 |
|||
1998 |
E |
0 |
0 |
0 |
0 |
- |
|
O |
0 |
0 |
0 |
0 |
|||
1999 |
E |
0 |
0 |
0 |
1 |
- |
|
O |
0 |
0 |
0 |
0 |
|||
2000 |
E |
0 |
0 |
2Td |
2* |
+ |
|
O |
0 |
0 |
1 |
1 |
|||
2001 |
E |
1 |
1 |
2 |
2 |
+ |
|
O |
0 |
0 |
1 |
1 |
|||
2002 |
E |
0 |
0 |
0 |
0 |
- |
|
O |
0 |
0 |
0 |
0 |
|||
2003 |
E |
0 |
0 |
1 |
0 |
- |
|
O |
0 |
0 |
0 |
0 |
|||
2004 |
E |
1 |
1 |
1 |
2 |
+ |
|
O |
0 |
0 |
0 |
1 |
* Dryness and sloughing of the epidermis
Td Thickening, dryness and sloughing of the epidermis
A Anterior site, exposed to the test item, 20% w/v in vehicle
P Posterior site, exposed to the test item, 10% w/v in vehicle
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- The test substance induced delayed contact hypersensitivity in 5 out of 10 (50%) guinea pigs with an intradermal induction dose of 2.5% .
Since more than 30% of the animals responded at an intradermal induction dose of more than 1%, the substance is considered as a moderate sensitizer and is therefore classified Skin Sensitizer category 1 and sub- category 1B according to Regulation (EC) No. 1272/2008 and its subsequent amendments on classification, labeling and packaging (CLP) of substances and mixtures. - Executive summary:
The potential of the test substance to induce delayed contact hypersensitivity was assessed in guinea pigs according to OECD guideline 406 and in compliance with Good Laboratory Practice.
The induction phase was realized both by the intradermal route on day 1 (Test material 2.5% in Alembicol D (coconut oil) or vehicle) and by the cutaneous route on day 8 (Test material 60% in Alembicol D or vehicle) in 2 groups of guinea pigs: 10 in the treated group and 5 in the control group.
The challenge phase was realized on day 22 by cutaneous application of the test material at 20% and 10% in Alembicol D. The cutaneous reactions were scored 24 and 48 hours after the challenge phase.Hexyl cinnamic aldehyde was used as a positive control and induced positive sensitization responses for nine of the ten test animals and therefore confirmed the sensitivity and reliability of the study.
In the control group, at the 24 and 48-hour readings, no cutaneous reactions were observed except in 1 animal at the 48 -hour reading that showed dryness and sloughing of the epidermis after challenge with the concentration of 20% . In the treated group, a slight erythema (grade1) was noted in 4 of the 10 animals at the 24 hour reading for both concentrations.
At the 48 hour reading, a slight or well-defined erythema (grade 1 or 2) together with a slight oedema (grade 1) was observed in 5 of the 10 animals for both concentrations. In addition, thickening, dryness and sloughing of the skin was noted in 1 animal.The persistent cutaneous reactions observed in 5 of the 10 animals of the test item-treated group were attributed to delayed contact hypersensitivity.
It was therefore concluded that the test substance was a skin sensitizer.
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.
Although ECHA is providing a lot of online material in your language, part of this page is only in English. More about ECHA’s multilingual practice.
Welcome to the ECHA website. This site is not fully supported in Internet Explorer 7 (and earlier versions). Please upgrade your Internet Explorer to a newer version.
the-echa-website-uses-cookies
find-out-more-on how-we-use-cookies