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EC number: 234-054-3 | CAS number: 10519-11-6
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15 May 2000 - 23 May 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- The standard information requirements for REACH Annex VII substances for serious eye damage/eye irritation can be satisfied by an assessment of the available in vivo data, physicochemical properties (i.e. acid or alkali reserve) or in vitro eye irritation studies. Conducted prior to the validation and regulatory acceptance of alternative methods, the reliable (Klimisch 1) and GLP compliant in vivo Draize test was available for the test substance and considered sufficient to fulfil the information requirement.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- 1997
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Decahydro-2-naphthyl acetate
- EC Number:
- 234-054-3
- EC Name:
- Decahydro-2-naphthyl acetate
- Cas Number:
- 10519-11-6
- Molecular formula:
- C12H20O2
- IUPAC Name:
- decahydronaphthalen-2-yl acetate
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Chbb:FIM(SPF) - Littlerussian
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Species: Little Russian SPF albino rabbits (Chbb:HM(SPF))
- Sex: Females
- Source: BI Pharma KG, 88297 Biberach
- Weight at study initiation: 2.7 - 3.0 kg b.w.
- Housing: Rabbits were caged individually in PPO cages (floor area: 2576 sq.cm) with perforated floor
- Diet (e.g. ad libitum): Pelleted complete rabbit diet, ad libitum
- Water (e.g. ad libitum): Domestic quality drinking water acidified with hydrochloric acid to pH 2.5 in order to prevent microbial growth, ad libitum
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C
- Humidity (%): 55 ± 15%
- Air changes (per hr): 10 times/hr
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours darkness
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1 mL
- Purity: 98.9 %
- Concentration (if solution): Undiluted - Duration of treatment / exposure:
- Single exposure
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 4
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): The eyes were rinsed with 20 ml 0.9% sodium chloride solution after Fluorescein was instilled.
- Time after start of exposure: The eyes were examined and the grade of ocular reaction was recorded one hour and 24 hours later. After the first 24 hour reading Fluorescein was instilled. The eyes were also examined 48 and 72 hours as well as 7 days after the treatment.
SCORING SYSTEM: Cornea reactions were scored both before and alter the instillation of Fluorescein.
- Opacity degree of density was evaluated on a scale of 0 (o ulceration or opacity) to 4 (complete corneal opacity, iris not discernible) and area of cornea involved was evaluated on a scale of 1 (one quarter (or less) but not zero) to 4 (more than 3 quarters, up to whole area).
- The iris was evaluated on a scale of 0 (normal) to 2 (no reaction to light, haemorrhage, gross destruction (any or all of these)).
- Conjunctiva redness (palpebral and bulbar conjunctivae excluding cornea and iris) was evaluated ona scale of 0 (vessels normal) to 3 (diffuse beefy red), chemosis was evaluated on a scale of 0 (no swelling) to 4 (swelling with lids more than half closed), and discharge was evaluated on a scale of 0 (no discharge) to 3 (discharge with moistening of the lids and hairs, and considerable area around the eye).
ASSESSMENT
- Scoring was evaluated in line with the directive of the Commission 93/21/EEC of May 4, 1993 which stated that “a substance of a preparation is considered to be irritant if it causes ocular lesions which occur within 72 hours after exposure and which persists for at least 24 hours. Ocular lesions are significant if the mean scores of the eye irritation test have any of the following values: Cornea opacity ≥2 but <3; Iris lesion ≥1 but <1.5; Redness of conjunctivae ≥2.5; Oedema of conjunctivae (chemosis) ≥2
A substance or a preparation is considered to be able to cause serious damage to eyes if it causes severe ocular lesions which occur within 72 hours after exposure and which persist for at least 24 hours”.
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: After instillation of Fluorescein, 24 hours after test item application, one animal had a cornea opacity score of 1.
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 1
- Remarks on result:
- other: One hour after application, two animals had an iris score of 1
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Discharge was observed in all animals 1 hour after test item application (max score = 2) and redness was observed in 3 animals up to 48 hours after test item application and in 1 animal up to 72 hours after test item application (max score = 2).
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Chemosis was observed in 2 animals up to 24 hours after test item application and in 2 animals up to 48 hours after test item application (max score = 2).
- Irritant / corrosive response data:
- Animal 1: A discharge with moistening of the lids and hairs just adjacent to lids (score = 2) was observed 1 hour after application of the test article. Diffuse, crimson red conjunctiva with individual vessels not easily discernible (score = 2) and a swelling above normal (score = 1) were observed 1 and 24 hours after application, and some conjunctival vessels definitely injected (score = 1) were observed 48 hours after application. Animal 1 was free of any signs of eye irritation at 72 hours after application.
Animal 2: An iris with markedly deepened folds, congestion, swelling, moderate circumcorneal injection and existence of reaction to light (score = 1) and a discharge with moistening of the lids and hairs just adjacent to lids (score = 2) were observed at 1 hour after application. A diffuse, crimson red conjunctiva with individual vessels not easily discernible (score = 2) as well as an obvious swelling with partial eversion of lids (score = 2) were observed after 1 and 24 hours. Scattered or diffuse area of opacity on one quarter or less of cornea was observed after instillation of Fluorescein (score = 1). Conjunctival vessels definitely injected (score = 1) and swelling above normal.(score = 1) were observed at 48 hours and some conjunctival vessels definitely injected (score = 1) was observed at 72 hours. Animal 2 was free of any signs of eye irritation at 7 days after application.
Animal 3: An iris with markedly deepened folds, congestion, swelling, moderate circumcorneal injection and existence of reaction to light (score = 1) and a discharge different from normal (score = 1) were observed 1 hour application. A diffuse, crimson red conjunctiva with individual vessels not easily discernible (score = 2) as well as an obvious swelling with partial eversion of lids (score = 2) were observed 1 and 24 hours after application. Conjunctival vessels definitely injected (score = 1) and swelling above normal (score = 1) were observed at 48 hours. Animal 3 was free of any signs of eye irritation at 72 hours after application.
Animal 4: A diffuse, crimson red conjunctiva with individual vessels not easily discernible (score = 2), a swelling above normal (score = 1) and a discharge different from normal (score = 1) were observed 1 hour after application. Swelling above normal (score = 1) was observed 24 hours after application and some conjunctival vessels definitely injected (score = 1) were observed 24 and 48 hours after application. Animal 4 was free of any signs of eye irritation at 72 hours after application.
Any other information on results incl. tables
Table 1. Individual mean eye irritation scores
Parameter | Animal 1 | Animal 2 | Animal 3 | Animal 4 |
Cornea opacity, degree | 0.00 | 0.00 | 0.00 | 0.00 |
Iris | 0.00 | 0.00 | 0.00 | 0.00 |
Conjunctiva redness | 1.00 | 1.33 | 1.00 | 0.67 |
Conjunctiva chemosis | 0.33 | 1.00 | 1.00 | 0.33 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The mean scores of cornea opacity, iris lesion, conjunctiva redness and conjunctiva oedema (chemosis) were 0.0, 0.0, 1.0 and 0.7, respectively. All animals were free of any signs of eye irritation after 7 days.
- Executive summary:
Eye irritation of the test item was tested in four female albino rabbits. An undiluted volume (0.1 mL) of the test item was administered one rabbit eye, whilst the other eye served as a control. Effects on the cornea, iris and conjunctiva were recorded at 1, 24, 48 and 72 hours and 7 days after application. The mean scores of cornea opacity, iris lesion, conjunctiva redness and conjunctiva oedema (chemosis) were 0.0, 0.0, 1.0 and 0.7, respectively. All animals were free of any signs of eye irritation after 7 days. According to the directive of the EEC commission 93/21/EEC (4 May 1993), the test item should not be classified as eye irritating.
Conducted according to OECD Guideline 405 and EU Method B.5 and GLP, the study was considered to be reliable without restriction (Klimisch 1).
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