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EC number: 276-481-8 | CAS number: 72214-18-7
- Life Cycle description
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- Endpoint summary
- Appearance / physical state / colour
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- Particle size distribution (Granulometry)
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- Endpoint summary
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- 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
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- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
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- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
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- Additional toxicological data

Endpoint summary
Administrative data
Description of key information
FAT 41001 is non-irritant to rabbit’s skin but is highly irritating (corrosive) to rabbit’s 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:
- 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- study predates GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- no
- Specific details on test material used for the study:
- Company code: FAT 41001/D
Batch No: EN 94060.32
Purity: 78.8 %
Appearance: Granulate
Stability of the test compound: until November 1988
pH-value: 7.6 (lg/1 water)
Test article received: December 6, 1983 - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation:12 - 14 weeks
- Weight at study initiation: 2000-2260 g
- Housing: Animals were housed individually in metal cages.
- Diet (e.g. ad libitum): Rabbit food, NAFAG, No. 814 Tox, NAFAG AG, Gossau, SG (Switzerland), ad libitum.
- Water (e.g. ad libitum): Water were provided ad libitum.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30-70
- Air changes (per hr): approximately 15 air changes/h
- Photoperiod (hrs dark / hrs light): 12 hours light/day - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- 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:
- 4 hours
- Observation period:
- 1. 24, 48, 72 hours
- Number of animals:
- 3 females
- Details on study design:
- SCORING SYSTEM:
After removal of the dressings the skin reaction was assessed on the basis of an evaluation scheme, (cf. Table 1), after 1, 24, 48, 72 hours and during the following observation period. The score obtained is defined as the "index of primary cutaneous irritation".
INDEX CLASSIFICATION
<0.5 non irritant
0.6 - 3.0 slightly irritant
3.1 - 5.0 irritant
5.1 - 8.0 severely irritant
Erythema and eschar formation:
- No erythema: 0
- Very slight erythema (barely perceptible): 1
- Well-defined erythema: 2
- Moderate to severe erythema: 3
- Severe erythema (beet redness) to slight eschar formation (injuries in depth): 4
Oedema formation:
- No oedema: 0
- Very slight oedema (barely perceptible): 1
- Slight oedema (edges of area well defined by definite raising): 2
- Moderate oedema (raised approximately 1 millimeter): 3
- Severe oedema (raised more than 1 millimeter and extending beyond the area of' exposure): 4 - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48h
- Remarks on result:
- other: only 1 animal could beassessed due to strong colouring of the skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The animals showed a normal body weight development. Starred figures indicate impossibility of scoring due to intensive blue staining by the test compound. The scoring was performed after the values for edema only.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 41001/D is non-irritant and not corrosive when applied to the rabbit skin; the test was terminated after 3 observation days.
- Executive summary:
The purpose of this study was to evaluate the primary skin irritation in Albino rabbits with compound FAT 41001/D. The test was carried out according to OECD guideline 404. Not less than 24 hours before treatment on the back of the experimental animal an area was shaven of at least 6 sq.cm by means of an electric clipper. 0.5 ml of the test substance was applied to the skin by means of gauze and loosely held in place by adhesive but non irritating tape for a period of 4 hours. Erythema scoring was possible only in one animal since intensive staining was observed in other animals. The mean 24/48/72h score was recorded to be 0.33 for animal #1. The mean 24/48/72h oedema score was recorded to be 0. The animals showed a normal body weight development. No other reactions to treatment were recorded during the whole observation period. Based on the findings of the study, it can be concluded, that FAT 41001/D is non-irritant and not corrosive when applied to the rabbit skin. The test was terminated after 3 observation days.
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:
- 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- study predates GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- no
- Specific details on test material used for the study:
- Company code: FAT 41'001/D
Batch No: EN 94060.32
Purity: 78.8 %
Appearance: granulate
Stability of the test compound: until November 1988
pH-value: 7.6 (lg/l water)
Test article received: December 6, 1983 - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation: 1800-1990 g
- Weight at study initiation: 12 - 14 weeks
- Housing: Animals were housed individually in metal cages.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): approximately 15 air changes/h.
- Photoperiod (hrs dark / hrs light): 12 hours light/day - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The left eye remained untreated and served as a control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g - Duration of treatment / exposure:
- one second
- Observation period (in vivo):
- 1, 24, 48, and 72 hours
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- SCORING SYSTEM:
The irritating and/or corrosive potential of the test article (theoretical range: non-irritant - extremely irritant) was assessed on the basis of the maximum irritant effect observed
- in one or several of the ocular tissues (conjunctiva, iris, cornea), observed over the range of observation time
- in one or more animals and taking into account the reversibility of the effect.
TOOL USED TO ASSESS SCORE: hand-slit lamp
SCORING SYSTEM: Scale for scoring Ocular Lesions.
1.Cornea
(A) Opacity-degree of density (area most dense taken for reading)
- No opacity: 0
- Scattered or diffuse area, details of iris clearly visible: 1
- Easily discernible translucent areas, details of iris slightly obscured: 2
- Opalescent areas, no details of iris visible, size of pupil barely discernible: 3
- Opaque, iris invisible: 4
(B) Area of cornea involved
- One quarter (or less) but not zero: 1
- Greater than one quarter but less than half: 2
- Greater than half, but less than three quarters: 3
- Greater than three quarters, up to whole area: 4
AxBx5 Total maximum=80
2.Iris
(A) Values
- Normal: 0
- Folds above normal, congestion, swelling, circumcorneal injection (any or all of these or combination of any thereof) iris still reacting
to light (sluggish reaction is positive): 1
- No reaction to light, haemorrhage, gross destruction (any or all of these): 2
Ax5 Total maximum=10
3.Conjunctivae
(A) Redness (refers to palpebral and bulbar conjunctivae excluding cornea and iris)
- Vessels normal: 0
- Vessels definitely injected above normal: 1
- More diffuse, deeper crimson red, individual vessels not easily discernible: 2
- Diffuse beefy red: 3
(B) Chemosis
- No swelling: 0
- Any swelling above normal (includes nictitating membrane): 1
- Obvious swelling with partial eversion of lids: 2
- Swelling with lids about half closed: 3
- Swelling with lids about half closed to completely closed: 4
(C) Discharge'
- No discharge: 0
- Any amount different from normal (does not include small amounts observed" in inner canthus of normal animals): 1
- Discharge with moistening of the lids and hairs just adjacent to lids: 2
- Discharge with moistening of the lids and hairs, and considerable area around the eye: 3
Score (a+b+c)x 2 Total maximum=20 - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.55
- Max. score:
- 2
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- FAT 41001/D is severely irritant and corrosive when applied to the rabbit eye mucosa.
- Executive summary:
FAT 41001/D was evaluated for eye irritation potential according to the procedure prescribed by OECD test guideline 405. 3 male Albino rabbits were used to perform the test. 0.1 g of the test article was placed into the conjunctival sac of the right eye of each animal, after gently pulling away the lower lid from the eyeball. The lids were then held together for about one second in order to prevent loss of the test material. The left eye remained untreated and served as a control. The ocular reactions were examined 1, 24, 48, and 72h, 7 and 21 days after substance instillation and again during the following observation period. The 24/48/72h mean corneal opacity, iris, conjunctivae, chemosis scores were reported as 3, 1.55, 3 and 3.67 respectively. Iris and chemosis effects were not reversible within 21 days. No abnormal effects on body weight was observed. Based on the findings of the study, it can be concluded that FAT 41001/D is severely irritant and corrosive when applied to the rabbit eye mucosa.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
A key study was carried out to determine the acute dermal skin irritation/corrosion potential in the rabbits in accordance with OECD guideline 404. The animals showed a normal body weight development. It can be concluded, that FAT 41001/D (purity: 78.8%) is non-irritant and not corrosive when applied to the rabbit skin; the test was terminated after 3 observation days. A supporting study was carried out to determine the acute dermal skin irritation/corrosion potential in the rabbits according to OECD guideline 404.
Under the conditions of the present experiment FAT 41001 / C (purity: 26.1 % AS.) was found to be slightly irritant and not corrosive when applied to the rabbit skin. There was a clear tendency of recovery towards the end of the observation period of 7 days. The purpose of this supporting study was to evaluate the primary skin irritation in Albino rabbits with compound FAT 41001/A (purity 60%). The test was carried out according to the method given in the "Hazardous Substances Regulations" under the U.S. Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965). Twenty four hours after application of the test compound, slight erythema and edema was present in 4/6 and 6/6 animals respectively. All test sites were normal after 72 hours. The primary irritation score was 1.0. FAT 41001/A is a slight primary skin irritant in the albino rabbit. Considering the above results from key and supporting studies it can be concluded that FAT 41001 is non-irritant to rabbit’s skin. A key study was carried out to determine the acute eye irritation/corrosion potential in the rabbits in accordance with OECD guideline 405. Under the conditions of the present experiment FAT 41001/D (purity: 78.8 %) was found to be severely irritant and corrosive when applied to the rabbit eye mucosa.
In supporting study, FAT 41001 / C was found to be slightly irritant and not corrosive when applied to the rabbit eye mucosa. There was a clear tendency of recovery towards the end of the observation period of 7 days. In another supporting study, the test was carried out in accordance with the procedure set out in the "Hazardous Substances Regulations" under the U.S.A. Federal Hazardous Substances Labelling Act Sect. 191.12 (February 1965), with slight modification. Within one hour of application of the test compound, there was a conjunctival reaction in 6/5.animals, together with superficial ulceration and/or opacity of the cornea in 5/5. All eyes were normal by day 6 except for blue staining of the conjunctivae and corneas in some animals. FAT 41001/A (purity: not known) is a slight eye irritant in the albino rabbit. Considering the above results from key and supporting studies it can be concluded that FAT 41001 is highly irritating to rabbit’s eye.
Justification for selection of skin
irritation / corrosion endpoint: Non-GLP guideline study
Justification for selection of eye irritation endpoint: NON-GLP
guideline study
Effects on eye irritation: highly irritating (corrosive)
Justification for classification or non-classification
FAT 41001 is non-irritant to rabbit’s skin but is highly irritating to rabbit’s eye.
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