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EC number: 274-503-0 | CAS number: 70247-74-4
- 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
Test substance was found to be non-irritant when applied to the intact or abraded rabbit skin as well as to rabbit eye mucosa.
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:
- 18 July 1974
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO).
- Deviations:
- no
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- other: Russian breed
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation:1.9 to 2.2 kg
- Housing:They were housed singly in metal cages (overall dimensions 47x32x34 cm).
- Diet: standard diet of Nafag ad libitum
- Water: ad libitum
- Acclimation period: at least 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C):18±1
- Humidity (%):55±-5
- Photoperiod (hrs dark / hrs light):14 hours light/day - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Remarks:
- electric clipper
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.5 g - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 7 days
- Number of animals:
- 6 rabbits (3 males and 3 females)
- Details on study design:
- The shaved skin area on the left side was slightly scarified just before treatment. A gauze patch of 2.5 x 2.5 cm laden with test substance was applied immediately to the prepared skin. The patch was covered with an impermeable foil of 5x5 cm, which was fixed to the body of the animals with adhesive tape. FAT 20 035/A was applied to each side in quantities of 0.5 g. Before application the test material was wetted with tap water. The gauze patches were removed 24 hours after application.
Assessment of irritation
0 = none
>0-1 = minimal
>1 - 2 = slight
>2 - 4 = moderate
>4 - 6 = marked
>6 - 8 = extreme - Irritation parameter:
- erythema score
- Remarks:
- intact and abraded skin
- Basis:
- mean
- Remarks:
- 6 animal
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- intact and abraded skin
- Basis:
- mean
- Remarks:
- 6 animal
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Remarks:
- intact and abraded skin
- Basis:
- mean
- Remarks:
- 6 animal
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- intact and abraded skin
- Basis:
- mean
- Remarks:
- 6 animal
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- intact and abraded skin
- Basis:
- mean
- Remarks:
- 6 animal
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Remarks:
- intact and abraded skin
- Basis:
- mean
- Remarks:
- 6 animal
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Remarks:
- 6 animal
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Non-irritant and non corrosive.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 20035/A was found to be non-irritant when applied to intact or abraded rabbit skin.
- Executive summary:
A in vivo test was carried out for finding out the primary irritation index as a measure of the acute irritation on the skin of rabbits with test compound FAT 20035. The method followed was patch test technique as described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO).
6 rabbits (3 male and 3 female) were observed for 7 days after test substance application. The shaved skin area on the left side was slightly scarified just before treatment. A gauze patch of 2.5 x 2.5 cm laden with test substance was applied immediately to the prepared skin. The patch was covered with an impermeable foil of 5x5 cm, which was fixed to the body of the animals with adhesive tape. FAT 20 035/A was applied to each side in quantities of 0.5 g . Before application the test material was wetted with tap water. The gauze patches were removed 24 hours after application.
Results showed no adverse reactions at all at any experimental time period, erythema and edema score at 24, 48 and 72 h was '0'. Under the conditions of this experiment FAT 20035/A was found to be non-irritant when applied to the intact or abraded rabbit skin.
Reference
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:
- 31 Jul 1943- 06 August 1974
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO).
- Deviations:
- no
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- other: Russian breed
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation:1.8 to 2.2 kg
- Housing: kept separately in metal cages (overall dimensions 47x32x34cm)
- Diet: standard diet of Nafag ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 1
- Humidity (%): 55 ± 5
- Photoperiod (hrs dark / hrs light): 14 hours light/day - Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g - Duration of treatment / exposure:
- 1 minute
- Observation period (in vivo):
- 1, 2,3 and 7 days
- Number of animals or in vitro replicates:
- 6 rabbits (3 males and 3 females)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done):The eyes of 3 animals were rinsed 1 minute after application with physiologic saline.
SCORING SYSTEM:
0-10 = minimal
11 - 25 = slight
26 - 55 = moderate
56 - 85 = marked
86 - 110 = extreme
TOOL USED TO ASSESS SCORE: slit lamp - Irritation parameter:
- cornea opacity score
- Remarks:
- unrinsed and rinsed eyes
- Basis:
- mean
- Remarks:
- 6 animal
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Remarks:
- unrinsed and rinsed eyes
- Basis:
- mean
- Remarks:
- 6 animal
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- unrinsed and rinsed eyes
- Basis:
- mean
- Remarks:
- 6 animal
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- unrinsed and rinsed eyes
- Basis:
- mean
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- conjunctivae score
- Remarks:
- unrinsed and rinsed eyes
- Basis:
- mean
- Remarks:
- 6 animal
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Remarks:
- unrinsed and rinsed eyes
- Basis:
- mean
- Remarks:
- 6 animal
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Other effects:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 20035/A was found to be practically non irritant when applied to the rabbit eye mucosa.
- Executive summary:
A study was performed to determine the eye irritation potential of FAT 20035/A on rabbits. Test method was followed as described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO). The substance was tested on 6 rabbits of the Russian breed. Amounts of 0.l g of the test substance were introduced into the conjunctival sac of the left eye with a spatula . After application, the eyelids were held open for a few seconds. The right eye was left untreated and served as a control. The eyes of 3 animals were rinsed 1 minute after application with physiologic saline. The reactions were appraised with a slit lamp after 1 and 6 hours; 1; 2; 3 and 7 days on the basis of "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the AFDO. Preparation FAT 20035/A was found to be practically non-irritant when applied to the rabbit eye mucosa. Minimal transient conjunctival reaction was noted 1 and 6 hours following instillation. After 24 hours all findings were negative in 2/3 unrinsed and 1/3 rinsed eyes. It can be concluded that FAT 20035/A is practically non irritant when applied to the rabbit eye mucosa.
Reference
Preparation FAT 20 035/A was found to be practically non irritant when applied to the rabbit eye mucosa. Minimal transient conjunctival reaction was noted 1 and 6 hours following instillation. After 24 hours all findings were negative in 2/3 unrinsed and 1/3 rinsed eyes.
Calculation of the primary eye irritation index
time after exposure h |
mean reaction score of 3 rabbits |
|||||
unrinsed eyes (A) |
rinsed eyes (B) |
|||||
cornea |
iris |
conjunctiva |
cornea |
iris |
conjunctiva |
|
6 |
0 |
0 |
4.0 |
0 |
0 |
4.7 |
24 |
0 |
0 |
2.0 |
0 |
0 |
2.0 |
72 |
0 |
0 |
0 |
0 |
0 |
0 |
subtotal |
0 |
0 |
6.0 |
0 |
0 |
6.7 |
total |
6.0 |
6.7 |
primary irritation index in unrinsed eyes A = 6.0 :3 = 2.0
primary irritation index in rinsed eyes P. = 6.7 -"3 = 2.2
effect of rinsing R = A / B = 2.0 / 2.2 = 0.9
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In vivo skin irritation:
A in vivo test was carried out for finding out the primary irritation index as a measure of the acute irritation on the skin of rabbits with test compound FAT 20035/A. The method followed was patch test technique as described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO). 6 rabbits (3 male and 3 female) were observed for 7 days after test substance application. The shaved skin area on the left side was slightly scarified just before treatment. A gauze patch of 2.5 x 2.5 cm laden with test substance was applied immediately to the prepared skin. The patch was covered with an impermeable foil of 5x5 cm, which was fixed to the body of the animals with adhesive tape. FAT 20 035/A was applied to each side in quantities of 0.5 g. Before application the test material was wetted with tap water. The gauze patches were removed 24 hours after application. Results showed no adverse reactions at all at any experimental time period, erythema and edema score at 24, 48 and 72 h was '0'. Under the conditions of this experiment FAT 20035/A was found to be non-irritant when applied to the intact or abraded rabbit skin.
In vivo eye irritation:
A study was performed to determine the eye irritation potential of FAT 20035/A on rabbits. Test method was followed as described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO). The substance was tested on 6 rabbits of the Russian breed. Amounts of 0.l g of the test substance were introduced into the conjunctival sac of the left eye with a spatula. After application, the eyelids were held open for a few seconds. The right eye was left untreated and served as a control. The eyes of 3 animals were rinsed 1 minute after application with physiologic saline.
The reactions were appraised with a slit lamp after 1 and 6 hours; 1; 2; 3 and 7 days. Preparation FAT 20035/A was found to be practically non-irritant when applied to the rabbit eye mucosa. Minimal transient conjunctival reaction was noted 1 and 6 hours following instillation. After 24 hours all findings were negative in 2/3 unrinsed and 1/3 rinsed eyes. It can be concluded that FAT 20035/A is practically non-irritant when applied to the rabbit eye mucosa.
Based on the results on in vivo skin and eye tests, FAT 20035/A can be regarded as practically non-irritant to rabbit skin and eyes.
Justification for classification or non-classification
Based on the findings in the skin and eye irritation study, the test substance does not considered to be classified according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 to be irritating to the skin as well as eyes.
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