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EC number: 429-960-2 | CAS number: 27610-48-6
- 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:
- 30.05.1986 to 07.07.1986
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study performed under GLP.
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4100 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- - Twenty female albino guinea-pigs of the Hartley/Dunkin strain were obtained from D. Hall, Newchurch, Staffordshire, England.
-The guinea-pigs were all acclimated to the laboratory environment.
- Each animal was identified by ear tattoo.
- The guinea-pigs were housed in suspended cages with wire mesh floors and they had free access to tap water and a Vitamin C-enriched Guinea-pig Diet F.D.1 (Special Diets Services Limited). Hay was given once weekly.
- Animal room temperature was approximately 21°C and relative humidity 30-70%.
- Air exchange was maintained at approximately 15 air changes per hour and lighting was controlled by means of a time switch to give 12 hours of artificial light in each 24 hour period. - Route:
- epicutaneous, occlusive
- Vehicle:
- other: Acetone in Alembicol D.
- Concentration / amount:
- The following concentrations of Epiclon EXA-4032 were selected:
-Induction: 1% v/v in 5% v/v acetone in Alembicol D.
-Challenge: 0.05% v/v in 5% v/v acetone in Alembicol D. - Route:
- epicutaneous, occlusive
- Vehicle:
- other: Acetone in Alembicol D.
- Concentration / amount:
- The following concentrations of Epiclon EXA-4032 were selected:
-Induction: 1% v/v in 5% v/v acetone in Alembicol D.
-Challenge: 0.05% v/v in 5% v/v acetone in Alembicol D. - No. of animals per dose:
- 10 test animals and 10 control animals
- Details on study design:
- Induction exposure:
-Prior to each induction application, the skin on the left shoulder region of the guinea-pig was clipped free of hair using electric clippers.
- A 2*2 cm patch of surgical gauze (3 layers thick) was satured with approximately 0.5 ml of Epiclon EXA-4032, 1% v/v in 5% v/v acetone in Alembicol D. The patch was placed on the skin and covered by a lenght of impermeable plastic adhaesive tape (5 cm with "blenderm". This in turn was firmly secured by elastic adhesive bandage (Elastoplast 5 cm width) wound round the torso of the animal and fixed with "Sleek" impervious plastic adhasive tape. Contact with the skin was maintained for approximately 6 hours for each induction exposure.
The dressing were then removed and the resulting dermal reactions assessed approximately 24 hours later for erythema and oedema.
Nine induction applications were made in this manner three times a week during a three week period. Due to the development of severe dermal reactions, the induction site was re-located on the fifth and then the eigh inductions.
Control animal:
-During the induction period the control animals were treated similary to the test animals with the exception that the test compound was omitted from the induction applications.
Challenge:
-The test and control animals were challenged topically two weeks after the ninth induction application using Epiclon EXA-4032, 0.05% v/v in 5% v/v acetone in Alembicol D.
- Hair was removed by clipping from a 5*5 area on the right flank of each guinea-pig. A 2*2 cm gauze patch (3 layers thick) was saturated with approximately 0.5 ml of the test sample in a similar fashion to that used for the induction applications. The patch was sealed to the flank for approximately 6 hours undr a 5 cm strip of "Blenderm" covered by "Elastoplast" wound round he trunk and secured with "Sleek".
Scores:
Erythema and eschar formation.
-No erythema: 0
-Slight erythema (barely perceptible): 1
-Well-defined erythema: 2
-Moderate erythema: 3
-Severe erythema (beet redness) to slight eschar formation (injuries in depth)
Oedema formation.
-No oedema: 0
-Slight oedema (barely perceptible): 1
-Well-defined oedema (edges of area well-defined by definite raising): 2
-Moderate oedema (raised approximately 1 millimetre): 3
-Severe oedema (raised more than 1 millimetre and extending beyond area of exposure): 4 - Challenge controls:
- The control animals were challenged topically two weeks after the ninth induction application using Epiclon EXA-4032, 0.05% v/v in 5% v/v acetone in Alembicol D.
- Hair was removed by clipping from a 5*5 area on the right flank of each guinea-pig. A 2*2 cm gauze patch (3 layers thick) was saturated with approximately 0.5 ml of the test sample in a similar fashion to that used for the induction applications. The patch was sealed to the flank for approximately 6 hours undr a 5 cm strip of "Blenderm" covered by "Elastoplast" wound round he trunk and secured with "Sleek". - Positive control substance(s):
- not specified
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.05%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.05%. No with. + reactions: 10.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.05%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.05%. No with. + reactions: 10.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.05%
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0.05%. No with. + reactions: 5.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.05%
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0.05%. No with. + reactions: 4.0. Total no. in groups: 10.0.
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- In this screening test, performed in ten albino guinea-pigs, Epiclon EXA-4032 produced evidence of delayed contact hypersensitivity in all ten animals.
- Executive summary:
This study was designed to assess skin sensitisation potential.This study was performed according Guidelines as described in the Federal Register, Vol. 50, N° 188, Part II of 27 September 1985, Section 798.4100_Dermal Sensitisation.
For the experiment, twenty female albio guinea-pigs were used (10 for the test animals and 10 for control animals).
The procedure may be considered in two parts: Inuction and Challenge.
The following concentrations of Epiclon EXA-4032 were selected:
-Induction: 1% v/v in 5% v/v acetone in Alembicol D.
-Challenge: 0.05% v/v in 5% v/v acetone in Alembicol D.
-All animals were observed daily for signs of ill health or toxic signs.
In this screening test, performed in 10 albino guinea-pigs, Epiclon EXA-4032 produced evidence of delayed contact hypersensitivity in all ten animals.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
This study was designed to assess skin sensitisation potential.This study was performed according Guidelines as described in the Federal Register, Vol. 50, N° 188, Part II of 27 September 1985, Section 798.4100_Dermal Sensitisation.
For the experiment, twenty female albio guinea-pigs were used (10 for the test animals and 10 for control animals).
The procedure may be considered in two parts: Inuction and Challenge.
The following concentrations of Epiclon EXA-4032 were selected:
-Induction: 1% v/v in 5% v/v acetone in Alembicol D.
-Challenge: 0.05% v/v in 5% v/v acetone in Alembicol D.
-All animals were observed daily for signs of ill health or toxic signs.
In this screening test, performed in 10 albino guinea-pigs, Epiclon EXA-4032 produced evidence of delayed contact hypersensitivity in all ten animals.
Migrated from Short description of key information:
This study was designed to assess skin sensitisation potential in the albino guinea-pig.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
- skin sensitisation:
Based on the above stated assessment of the skin sensitisation potential of 1,6-dihydroxynaphthalene diglycidyl ether, the substance needs to be classified as R43 (May cause sensitisation by skin contact) according to Council Directive 2001/59/EC (28th ATP of Directive 67/548/EEC) and Skin Sens. 1 (H317: may cause an allergic skin reaction) according 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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