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Diss Factsheets

Administrative data

Description of key information

The substance causes minimal irritation to the skin and eyes, however, it does not meet the criteria of irritation classification.

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:
Experiment start date - 04 February 1980; Experiment end date - 12 February 1980; Study completion date - 26 February 1980.
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: United States Environmental Agency (EPA) § 163.81- 5 "Primary dermal irritation study", Federal Register, Vol. 43, No. 163, August 22, 1978
Deviations:
no
GLP compliance:
not specified
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Code No. of test material as used in the study report: FAT 20037/B
- Physical appearance: solid
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: adult ones
- Weight at study initiation: 2 to 3 kgs
- Housing: individually in metal cages, numbered by ear tags
- Diet: standard rabbit food - NAFAG, No. 814, Gossau SG, ad libitum
- Water: ad libitum
- Acclimation period: minimum 4 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2 °C,
- Humidity (%): 55 ± 10 %
- Photoperiod: 10 hours light cycle day

IN-LIFE DATES: From: 04 February, 1980; To: 12 February, 1980
Type of coverage:
occlusive
Preparation of test site:
other: shaved, with one side abraded and one site kept intact
Vehicle:
unchanged (no vehicle)
Controls:
no
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 (3 males and 3 females)
Details on study design:
TEST SITE
- Type of wrap if used: Gauze patches of 2.5 x 2.5 cm laden with 0.5 g of the test material were applied to the prepared abraded and intact skin.

REMOVAL OF TEST SUBSTANCE
- Washing: yes
- Time after start of exposure: 24 hours
Irritation parameter:
erythema score
Remarks:
Intact skin
Basis:
mean
Remarks:
6 animals
Time point:
24/48/72 h
Score:
0.167
Max. score:
4
Reversibility:
fully reversible within: 72h
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Remarks:
Abraded skin
Basis:
mean
Remarks:
6 animals
Time point:
24/48/72 h
Score:
0.278
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Remarks:
Intact skin
Basis:
mean
Remarks:
6 animals
Time point:
24/48/72 h
Score:
0.167
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Remarks:
Abraded skin
Basis:
mean
Remarks:
6 animals
Time point:
24/48/72 h
Score:
0.278
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
The primary irritation index for FAT 20037/B was calculated to be 0.5, indicating potential to cause a minimal irritation when applied to intact and abraded rabbit skin.

Results:

Time after exposure (hours) Mean reaction score of 6 rabbits
Erythema Edema
Intact skin Abraded Skin Intact skin Abraded Skin
24 0.3 0.7 0.3 0.7
72 0 0 0 0
         
Total 0.3 0.7 0.3 0.7

Primary irritation index = (0.3 + 0.7 + 0.3 + 0.7)/4 = 2/4 = 0.5

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance was found to be a non-irritant to the skin.
Executive summary:

The irritation potential of the test item was evaluated in a study conducted according to the United States Environmental Agency (EPA) § 163.81- 5 "Primary dermal irritation study", Federal Register, Vol. 43, No. 163, August 22, 1978. 6 rabbits (3 males; 3 females) were used in this study. Gauze patches of 2.5 x 2.5 cm laden with 0.5 g of the test material were applied to the prepared abraded and intact skin for the exposure duration of 24 hours. The reaction of the skin was appraised upon removal during an observation period of 7 days. The scores read after 24 and 72 hours for erythema and edema for the intact as well as for the abraded skin were summed up and divided by 4. Minimal irritation was recorded at the 24 hour observation. The mean 24/48/72 hour scores were 0.167 and 0.278 for erythema and edema score, respectively, for intact skin. The erythema and edema was reversed within 72 hours. The primary irritation index was calculated to be 0.5, indicating potential to cause a minimal irritation when applied to intact and abraded rabbit skin. However, based on the EU CLP criteria, the test item can be classified as a non-irritant to the skin.

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:
Experiment start date - 04 February 1980; Experiment end date - 12 February 1980; Study completion date - 26 February 1980.
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: the United States Environmental Protection Agency (EPA) § 163.81-4 "Primary eye irritation study", Federal Register, Vol. 43, No. 163, August 22, 1978.
Deviations:
no
GLP compliance:
not specified
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Code No.of test material: FAT 20037/B
- Appearance: powder
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: In-house
- Age at study initiation: adult ones
- Weight at study initiation: 2 to 3 kgs
- Housing: individually in metal cages, numbered by ear tags
- Diet: ad libitum, standard rabbit food - NAFAG, No. 814, Gossau SG
- Water: ad libitum
- Acclimation period: minimum of 4 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2 °C
- Humidity: 55 ± 10 %
- Photoperiod: 10 hour light cycle day

IN-LIFE DATES: From: 4 February, 1980; To: 12 February, 1980
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
Duration of treatment / exposure:
In 3 of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 mL of physiological saline. No flushing was performed in remaining animals.
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6 (3 males and 3 females)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: Yes, In 3 of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 mL of physiological saline.

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 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:
Unrinsed 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:
Unrinsed 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:
Unrinsed eyes
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:
FAT 20037/B was found to cause no irritation to the rabbit eye mucosa.

Primary eye irritation index:

Time after exposure
days
Mean Reaction Score
Unrinsed eyes (A) Rinsed eyes (B)
Cornea Iris Conjuctiva Cornea Iris Conjuctiva
1 0 0 0 0 0 0
2 0 0 0 0 0 0
3 0 0 0 0 0 0
4 0 0 0 0 0 0
7 0 0 0 0 0 0
Subtotal 0 0 0 0 0 0
Total 0 0

primary irritation index in unrinsed eyes A = 0

primary irritation index in rinsed eyes B = 0

effect of rinsing R = A/B = 0

Interpretation of results:
GHS criteria not met
Conclusions:
FAT 20037/B can be classified as a non-irritant to the eye.
Executive summary:

The eye irritation potential of the test item was evaluated in a study conducted according to procedure described in the United States Environmental Protection Agency (EPA) § 163.81-4 "Primary eye irritation study", Federal Register, Vol. 43, No. 163, August 22, 1978. 6 rabbits (3 males; 3 females) were used in this study. 0.1 g was inserted into the conjunctival sac of the left eye of the rabbits and the lids were gently closed for a few seconds. The right eye was not treated and served as an untreated control. In 3 of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 mL of physiological saline. The eye irritation was appraised with a slit-lamp on day 1, 2, 3, 4 and 7 and was scored for each individual rabbit. The mean reaction scores for cornea, iris and conjunctiva observed after 1, 2, 3, 4 and 7 days were summed up and the sum divided by 5. This procedure was carried out separately for unrinsed (A) and rinsed (B) eyes, respectively. No irritant effects were observed for any parameters at any timepoints. The instillation was found to cause no irritation when applied to the rabbit eye mucosa. The primary irritation indices obtained with rinsed and unrinsed eye, were equal to 0. Hence, the test item can be classified as a non-irritant to the eye.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation:

The skin irritation/corrosion potential of the test substance was evaluated in two different in vivo studies. The irritation potential of the test item was evaluated in a key study conducted according to the United States Environmental Agency (EPA) § 163.81- 5 "Primary dermal irritation study", Federal Register, Vol. 43, No. 163, August 22, 1978. 6 rabbits (3 males; 3 females) were used in this study. Gauze patches of 2.5 x 2.5 cm laden with 0.5 g of the test material were applied to the prepared abraded and intact skin for the exposure duration of 24 hours. The reaction of the skin was appraised upon removal during an observation period of 7 days. The scores read after 24 and 72 hours for erythema and edema for the intact as well as for the abraded skin were summed up and divided by 4. Minimal irritation was recorded at the 24-hour observation. The primary irritation index was calculated to be 0.5, indicating potential to cause a minimal irritation when applied to intact and abraded rabbit skin. However, based on the EU CLP criteria, the test item can be classified as a non-irritant to the skin. In a supporting study, the irritation potential of the test item was evaluated using similar methodology. 6 rabbits (3 males; 3 females) were used in this study. Gauze patches of 2.5 x 2.5 cm laden with 0.5 g of the test material were applied to the prepared abraded and intact skin for the exposure duration of 24-hours. No erythema or edema was seen in this study. The primary irritation index was calculated to be 0.0. Hence, the test item can be classified as a non-irritant to the skin.

Eye irritation:

The eye irritation/corrosion potential of the test substance was evaluated in two different in vivo studies. The eye irritation potential of the test item was evaluated in a key study conducted according to procedure described in the United States Environmental Protection Agency (EPA) § 163.81-4 "Primary eye irritation study", Federal Register, Vol. 43, No. 163, August 22, 1978. 6 rabbits (3 males; 3 females) were used in this study. The test material in an amount of 0.1 g was inserted into the conjunctival sac of the left eye of the rabbits and the lids were gently closed for a few seconds. The right eye was not treated and served as an untreated control. In 3 of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 mL of physiological saline. The eye irritation was appraised with a slit-lamp on day 1, 2, 3, 4 and 7 and was scored for each individual rabbit. The mean reaction scores for cornea, iris and conjunctiva observed after 1, 2, 3, 4 and 7 days were summed up and the sum divided by 5. This procedure was carried out separately for unrinsed (A) and rinsed (B) eyes, respectively. The instillation found to cause no irritation when applied to the rabbit eye mucosa. The primary irritation indices obtained with rinsed and unrinsed eye, were equal to 0. Hence, the test item can be classified as a non-irritant to the eye. In a supporting study, the eye irritation potential of the test item was evaluated according to the 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 males; 3 females) were used in this study. 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 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, 6 and 8 days. The mean reaction scores for cornea, iris and conjunctiva observed after 6, 24 and 72 hours were summed up and the sum divided by 3. This procedure was carried out separately for unrinsed (A) and rinsed (B) eyes respectively. The instillation was found to cause transient slight irritation. The irritation consisted of conjunctival reaction in all and of transient reflex hyperemia of the iris in 2/3 unrinsed eyes. Transient corneal reaction was observed in 1/3 rinsed and 1/3 unrinsed eyes. Complete recovery occurred within 6 days. Rinsing the eyes following instillation was of practically no effect. The test item instillation lead to minimal irritation to eyes, however, the threhold scores for classification according to EU CLP criteria were not met. Hence, the test item can be classified as a non-irritant to the eye.

Justification for classification or non-classification

Based on the results of the available in vivo skin and eye irritation studies, the test substance does not warrant the classification according to CLP criteria.