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EC number: 405-520-5 | CAS number: 95235-30-6 D-8; DD-8
- 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
D-8 was tested for skin irritation in rabbits according to EU Test Guideline B.4. No skin irritation was observed in any of the six rabbits. D-8 can be regarded as non-irritant to the skin.
D-8 was tested for eye irritation in rabbits according to the US EPA TSCA guideline 798.4500. Instillation of D-8 into the rabbit eye did not elicit a positive response in any of the six treated animals according to T.S.C.A. test criteria. Therefore, D-8 was considered non-irritant to the rabbit eye.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1986-04-17 to 1986-06-11
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Froxfield Rabbits; Petersfield, Hampshire; England;
- Age at study initiation: approximately 11 to 12 weeks;
- Weight at study initiation: 2.4 to 2.7 kg;
- Housing: individually in metal cages with perforated floors;
- Diet: SDS Standard Rabbit Diet ad libitum;
- Water: tap water ad libitum;
- Acclimation period: not stated;
ENVIRONMENTAL CONDITIONS
- Temperature: approximately 19 °C;
- Humidity: 30 - 70 % R.H.;
- Air changes: approximately 19 air changes/min;
- Photoperiod: 12 hours light/12 hours dark;
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 g of test material
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 4 Days
- Number of animals:
- six males
- Details on study design:
- Approximately 24 hours prior to application of the test substance, hair was removed with electric clippers from the dorso-lumbar region of each rabbit exposing an area of skin approximately 10 cm square.
A 0.5 g amount of D-8 was applied under a 2.5 cm square gauze pad moistened with 0.5 mL of distilled water to one intact skin site of each animal.
Each treatment site was occluded with "Elastoplast" elastic adhesive dressing for a four hour period.
The animals were not restrained during the exposure period and were returned to their cages.
At the end of the exposure period, the semi-occlusieve dressing and gauze pad were removed and the treatment site was washed using distilled water to remove any residual test substance. - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- 1991
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- 1992
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- 1993
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Remarks:
- 1994
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Remarks:
- 1995
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Remarks:
- 1996
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- 1991
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- 1992
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- 1993
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Remarks:
- 1994
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Remarks:
- 1995
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Remarks:
- 1996
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- No signs of irritation observed.
- Other effects:
- No other effects observed.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- D-8 was tested for skin irritation in rabbits according to EU Test Guideline B.4. No skin irritation was observed in any of the six rabbits. D-8 can be regarded as non-irritant to the skin.
- Executive summary:
D-8 was tested for skin irritation in rabbits with an occlusive test. The substance was applied on the intact skin for four hours and subsequently removed by rinsing with water. The animals were observed for erythema and oedema on the following 4 days. No signs of dermal irritation was observed in any of the six animals. Therefore, D-8 was considered non-irritant to the skin.
- Endpoint:
- skin irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Referenceopen allclose all
No dermal irritation was observed in any of the six rabbits.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1986-04-24 to 1986-06-12
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4500 (Acute Eye Irritation)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Froxfield Rabbits; Petersfield, Hampshire; England;
- Age at study initiation: approximately 11 to 12 weeks;
- Weight at study initiation: 2.4 to 2.7 kg;
- Housing: individually in metal cages with perforated floors;
- Diet: SDS Standard Rabbit Diet ad libitum;
- Water: tap water ad libitum;
- Acclimation period: not stated;
ENVIRONMENTAL CONDITIONS
- Temperature: approximately 19 °C;
- Humidity: 30 - 70 % R.H.;
- Air changes: approximately 19 air changes/min;
- Photoperiod: 12 hours light/12 hours dark; - Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 33 mg occupying a volume of 0.1 mL
- Duration of treatment / exposure:
- 7 days
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6 males
- Details on study design:
- The eyes of each animal were examined prior to instillation of the test substance to ensure that there was no pre-existing corneal damage or conjunctival inflammation.
A 33 mg amount of D-8, the weight occupying a volume of 0.1 mL, was placed into the lower everted lid of one eye of each animal.
The eyelids were then gently hold together for one second before releasing. The contralateral eye remained untreated and served as a control. - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Instillation of D-8 into the rabbit eye did not elicit a positive response in any of the six treated animals according to the T.S.C.A. test criteria.
- Other effects:
- No other effects observed.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- D-8 was tested for eye irritation in rabbits according to the US EPA TSCA guideline 798.4500. Instillation of D-8 into the rabbit eye did not elicit a positive response in any of the six treated animals according to T.S.C.A. test criteria. Therefore, D-8 was considered non-irritant to the rabbit eye.
- Executive summary:
D-8 was tested for eye irritation according to test criteria in compliance with the guidelines of the US EPA Toxic Substance Control Act (TSCA). None of the tested animals gave a "positive" response. No corneal damage or iridial inflammation was observed in any of the animals. Transient mild conjunctival reactions were seen in five animals, with eyes normal two or three days after instillation. One animal did not show any observable response to treatment throughout the observation period. Therefore, according to the T.S.C.A. test criteria, D-8 was not considered to cause eye irritation effects.
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
Referenceopen allclose all
None of the animals gave a positive response.
No corneal damage or iridial inflammation was observed in any of the animals.
Transient mild conjunctival reactions were seen in five animals.
The eyes were normal two or three days after instillation.
One animal did not show any observable response to treatment throughout the observation period.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
D-8 was tested for skin irritation in rabbits with an occlusive test. The substance was applied on the intact skin for four hours and subsequently removed by rinsing with water. The animals were observed for erythema and oedema on the following 4 days. No signs of dermal irritation were observed in any of the six animals. Therefore, D-8 was considered non-irritant to the skin.
Eye irritation
D-8 was tested for eye irritation according to test criteria in compliance with the guidelines of the US EPA Toxic Substance Control Act (TSCA). None of the animals gave a "positive" response. No corneal damage or iridial inflammation was observed in any of the animals. Transient mild conjunctival reactions were seen in five animals. The eyes were normal two or three days after instillation. One animal did not show any observable response to treatment throughout the observation period. Therefore, D-8 did not elicit a positive response in any of the six treated animals according to the T.S.C.A. test criteria.
Justification for classification or non-classification
Classification, Labeling, and Packaging Regulation (EC) No 1272/2008
The available data for skin irritation/corrosion and eye irritation/corrosion are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on this data, the substance is neither considered to be classified for skin irritation/corrosion nor for eye irritation/corrosion under Regulation (EC) No 1272/2008, as amended for the twelfth time in Regulation (EU) No 2019/521.
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