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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
Reference
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
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.

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.