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Diss Factsheets

Administrative data

Description of key information

The test substance demontrated to be neither a skin irritant nor an eye irritant.

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:
21 October, 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
Principles of method if other than guideline:
As per the guideline
GLP compliance:
no
Specific details on test material used for the study:
- Identified as: FAT 40068/A
Species:
rabbit
Strain:
other: Russian breed
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 1.5 to 2 kgs
- Housing: kept separately in V2A wire cages
- Diet: NAFAG, Gossau SG, rabbit food ad libitum
- Water: ad libitum

IN-LIFE DATES: 1974
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
other: polyethylene glycol (PEG 400)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
FAT 40068/A was applied to each side in quantities of 0.5 g.
Duration of treatment / exposure:
24 h
Observation period:
72 h
Number of animals:
3 males and 3 females
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: The patch was covered with a plastic film 5 x 5 cm, which was fixed to the body with adhesive tape.

OBSERVATION TIME POINTS: The reaction of the skin was appraised upon removal and 72 hours after it.

SCORING SYSTEM:
Evaluation of Skin Reactions

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

Edema Formation
No edema...................................................................................................... 0
Very slight edema (barely perceptible).............................................................. 1
Slight edema (edges of area well defined by definite raising................................. 2
Moderate edema (raised approximately 1 mm).................................................. 3
Severe edema (raised more than 1 mm and extending beyond area of exposure)...4
Irritation parameter:
erythema score
Remarks:
Intact skin
Basis:
mean
Remarks:
6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Remarks:
Intact skin
Basis:
animal #1
Time point:
24 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Remarks:
Intact skin
Basis:
animal #2
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Remarks:
Intact skin
Basis:
animal #3
Time point:
24 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Remarks:
Intact skin
Basis:
animal #4
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Remarks:
Intact skin
Basis:
animal #5
Time point:
24 h
Score:
0
Max. score:
6
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Remarks:
Intact skin
Basis:
animal #6
Time point:
24 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Remarks:
Intact skin
Basis:
animal: 1, 2, 3, 4, 5, 6
Time point:
72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Time point:
48 h
Remarks on result:
not measured/tested
Irritant / corrosive response data:
In scarified skin, all erythema scores at 24 and 48 hours were zero. Edema score was observed as 1 and 2 for animal #2 and #4 respectively at 24h time point only.
Interpretation of results:
GHS criteria not met
Conclusions:
The test substance can be classified as a non-irritant.
Executive summary:

A study was conducted to determine the skin irritation potential of the test substance qas per the patch-test technique 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). Six rabbits (3 males/3 females) of the Russian breed, weighing 1.5 to 2 kgs, were shaved on the whole back and flanks two days before treatment with an electric clipper. The shaven skin on the left side was slightly scarified immediately before treatment. A gauze patch 2.5 x 2.5 cm was soaked with the test substance and immediately applied to the prepared skin. The patch was covered with a plastic film 5 x 5 cm, which was fixed to the body with adhesive tape. FAT 40068/A was applied to each side in quantities of 0.5 g. Before application a 50 % polyethylene glycol trituration (PEG 400) was made. The gauze patches were removed 24 hours after the application. The reaction of the skin was appraised upon removal and 72 hours after it. No erythema was observed in any animals at any time point. Slight edema was observed in 2/6 animals which was reversible at 72h. The primary irritation index of FAT 40068/A was 0.2. Hence, the test substance can be classified as a non-irritant.

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:
21 October, 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:
not specified
Principles of method if other than guideline:
As per the guideline
GLP compliance:
no
Specific details on test material used for the study:
Test material identified as: FAT 40068/A
Species:
rabbit
Strain:
other: Russian breed
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Housing: separately in V2A wire cages
- Diet: NAFAG, Gossau SG, rabbit food ad libitum
- Water: ad libitum

IN-LIFE DATES: 1974
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 g
Duration of treatment / exposure:
After application, the eyelids were held open for a few seconds. The treated eyes of three rabbits were each rinsed with 10 mL lukewarm water about 30 seconds after treatment.
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3 males and 3 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: The treated eyes of three rabbits (out of 6) were each rinsed with 10 mL lukewarm water about 30 seconds after treatment.

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

TOOL USED TO ASSESS SCORE: slit lamp
Irritation parameter:
cornea opacity score
Remarks:
Rinsed eyes
Basis:
mean
Remarks:
3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Remarks:
Rinsed eyes
Basis:
mean
Remarks:
3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
Rinsed eyes
Basis:
mean
Remarks:
3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Remarks:
Rinsed eyes
Basis:
mean
Remarks:
3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Remarks:
Unrinsed eye
Basis:
mean
Remarks:
3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Remarks:
Unrinsed eye
Basis:
mean
Remarks:
3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
Unrinsed eye
Basis:
mean
Remarks:
3 animals
Time point:
24/48/72 h
Score:
0.55
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Remarks:
Un rinsed eye
Basis:
mean
Remarks:
3 animals
Time point:
24/48/72 h
Score:
0.55
Max. score:
4
Reversibility:
fully reversible within: 72h
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
The primary-irritation index, which serves as a measure of the acute irritation provoked by the substance, was found to be 0 for the cornea, 0 for the iris and 1 for the conjunctiva.
Interpretation of results:
GHS criteria not met
Conclusions:
The test substance does not meet the GHS criteria for classification, hence can be considered as not an irritant to eye.
Executive summary:

A study was conducted to evaluate the eye irritation potential of the test substance. The procedure adopted was as per the technique 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 (3 males/3 females) of the Russian breed. Amounts of 0.1 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 served as a control. The treated eyes of three rabbits were each rinsed with 10 mL lukewarm water about 30 seconds after treatment. The reactions were appraised with a slit-lamp after 24 hours and after 2, 3, 4 and 7 days on the basis of the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the AFDO. No cornea, iris or conjuctival irritation was observed for rinsed eyes. Slight conjuctvial irritation was reported in the animals with eyes not rinsed, which was completely reversed by 72h. The irritation index was found to be 0 for the cornea, 0 for the iris and 1 for the conjunctivae. Based on the findings of the study, the test substance does not meet the GHS criteria for classification, hence can be considered as not an irritant to eye.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation:

 A study was conducted to determine the skin irritation potential of the test substance according to the patch-test technique 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). Six rabbits (3 males/3 females) of the Russian breed, weighing 1.5 to 2 kgs, were shaved on the whole back and flanks two days before treatment with an electric clipper. The shaven skin on the left side was slightly scarified immediately before treatment. A gauze patch 2.5 x 2.5 cm was soaked with the test substance and immediately applied to the prepared skin. The patch was covered with a plastic film 5 x 5 cm, which was fixed to the body with adhesive tape. FAT 40068/A was applied to each side in quantities of 0.5 g. Before application a 50 % polyethylene glycol trituration (PEG 400) was made. The gauze patches were removed 24 hours after the application. The reaction of the skin was appraised upon removal and 72 hours after it. No erythema was observed in any animals at any time point. Slight edema was observed in 2/6 animals which was reversible at 72h. The primary irritation index of FAT 40068/A was 0.2. Hence, the test substance can be classified as a non-irritant.

Eye irritation:

A study was conducted to evaluate the eye irritation potential of the test substance. The procedure adopted was as per the technique 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 (3 males/3 females) of the Russian breed. Amounts of 0.1 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 served as a control. The treated eyes of three rabbits were each rinsed with 10 mL lukewarm water about 30 seconds after treatment. The reactions were appraised with a slit-lamp after 24 hours and after 2, 3, 4 and 7 days on the basis of the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the AFDO. No cornea, iris or conjuctival irritation was observed for rinsed eyes. Slight conjuctvial irritation was reported in the animals with eyes not rinsed, which was completely reversed by 72h. The irritation index was found to be 0 for the cornea, 0 for the iris and 1 for the conjunctivae. Thus, based on the findings of the study, the test substance does not meet the GHS criteria for classification, hence can be considered as not an irritant to eye.

Justification for classification or non-classification

Based on the results of the skin and eye irritation studies, the substance does not warrant the classification under CLP (1272/2008) Regulation.