Registration Dossier

Administrative data

Description of key information

The substance was found to cause irritation to skin as well as eyes.

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:
March 3, 1983 to March 14, 1983
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
None
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
no
Specific details on test material used for the study:
None
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414, Fuellinsdorf
- Number and sex of animals used: 3 males
- Age at study initiation: 12 - 14 weeks
- Weight at study initiation: 2085 - 2150 g
- Housing: individually in metal cages
- Diet: standard rabbit food - NAFAG, No. 814 Tox, Gossau SG (Switzerland), ad libitum
- Water: ad libitum
- Acclimation period: minimum 4 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3 °C,
- Humidity (%): 30 - 70 %
- Photoperiod: 12 hours light cycle day
- Air changes: approximately 15 air changes/h
Type of coverage:
semiocclusive
Preparation of test site:
shaved
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:
4 hours
Observation period:
7 days
Number of animals:
3 males
Details on study design:
- Application of the Substance: Not less than 24 hours before treatment, on the back of experimental animal, an area was shaven of at least 6 sq cm, by means of an electrical clipper. A gauze patch bearing 0.5 g of the test substance was applied to the skin and loosely held in place by adhesive but not irritating tape. The substance was moistened before application.

REMOVAL OF TEST SUBSTANCE
- Washing: not specified

Study evaluation
- Scoring of symptoms, and local reactions: After removal of the dressings the skin reaction was assessed on the basis of an evaluation scheme, after 1, 24, 48, 72 hours and during the following observation period.
- Symptoms: daily (a.m. and p.m. on working days, once daily on weekends and holidays).
- Body weight: At beginning of acclimatisation and end of test
- Mortality: daily (a.m. and p.m. on working days, once daily on weekends and holidays).
Other effects / acceptance of results:
None
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 1, 24, 48 and 72 h
Score:
3.3
Max. score:
8
Reversibility:
not fully reversible within: 7 days
Other effects:
The body weight development was in one animal only affected by the application of the test article.
No other reactions to treatment were recorded during the whole observation period.

Observations:

The scores obtained are presented in the below tables:

Erythema and eschar
Animal 1 hour 24 hours 48 hours 72 hours  7 days
31 2 2 2 2 1
32 2 2 2 2 2
33 1 1 1 1 1
Total 5 5 5 5 A = 20 
 Avg score 1.67 1.67 1.67 1.67  

Oedema
Animal 1 hour 24 hours 48 hours 72 hours  7 days
31 2 2 2 2 1
32 2 2 2 2 2
33 1 1 1 1 1
Total 5 5 5 5 B = 20 
  1.67 1.67 1.67 1.67  

INDEX of skin irritation : A 20 + B 20 = 40 : 12 = 3.33

Interpretation of results:
GHS criteria not met
Conclusions:
FAT 31016/I was considered as an irritant to the skin.
Executive summary:

The irritation potential of FAT 31016/I was evaluated in a study conducted according to OECD Guideline 404.3 male rabbits were used in this study. A gauze patch with 0.5 g of the test material was applied to the prepared skin of the rabbitsfor the exposure duration of 4 hours. The reactions of the skin were appraised upon removal during an observation period of 7 days. The sum of scores read after 1, 24, 48 and 72 hours for erythema and edema were summed up and divided by 12 to get the primary irritation index, which was calculated to be 3.33.The mean individual scores for erythema as well as edema (mean of scores recorded at 24, 48 and 72 hours) for all 3 animals were 1.67 each. Hence, the criteria of "mean value of ≥ 2.3 - ≤ 4.0 for erythema/eschar or for oedema in at least 2 of 3 tested animals from gradings at 24, 48 and 72 hours", required for classification of the substance as irritant was not attained. However, till the end of observations (day 7), erythema as well as edema were found to be persistent. Hence taking a conservative approach, owing to the lack of details regarding the reversibility of skin reactions, the substance was concluded to be an irritant to the skin.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (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:
April 11, 1983 to April 28, 1983
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
None
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
OECD guidelines for testing of chemicals: Acute Eye Irritation/Corrosion No. 405, adopted May 12, 1981 by the OECD Council.
Deviations:
no
Principles of method if other than guideline:
None
GLP compliance:
no
Specific details on test material used for the study:
- Company code: FAT 31'016/I
- Batch No.: RZ 3068/37,
- Appearance: powder
- Stability of the test compound: until October 2012
- Teat article received: October 25, 1982
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Source: Kleintierfarm Madoerin AG, CH-4414, Fuellinsdorf.
The test was performed on 3 female New Zealand white rabbits weighing 2.3 to 2.6 kgs and aging between 12-14 weeks. They were housed individually in metal cages, were kept in a room maintained at a constant temperature of 20±3 °C, at a relative humidity of 30-70% and on a 12 hours light cycle day, with approximately 15 air changes/h. The animals received ad libitum standard rabbit food - NAFAG, No. 814, Gossau SG (Switzerland) and water. Prior to treatment they were acclimatized to the laboratories for a minimum of 4 days. Only rabbits with normal ophthalmic findings were used for these tests.
Vehicle:
unchanged (no vehicle)
Controls:
other: The left eye was not treated and served as the control.
Amount / concentration applied:
0.1 g
Duration of treatment / exposure:
Not specified
Observation period (in vivo):
17 days
Number of animals or in vitro replicates:
3 females
Details on study design:
- Application of the test article:
0.1 g of FAT 31016/I was placed into the conjunctival sac of the right eye of each rabbit, 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.

- Scoring and assessment of local reactions:
The ocular reactions were examined 1, 24, 48, and 72 hours after substance instillation and again during the following observation period.
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.

- Symptoms: daily (a.m. and p.m. on working days, once daily on weekends and holidays)
- Body weight: at begin of the acclimatisation and end of test
- Mortality: daily (a.m. and p.m. on working days, once daily on weekends and holidays)
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
2.6
Max. score:
4
Reversibility:
not fully reversible within: 17 d
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
1.33
Max. score:
2
Reversibility:
not fully reversible within: 17 d
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
2.78
Max. score:
3
Reversibility:
not fully reversible within: 17 d
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
2.78
Max. score:
4
Reversibility:
not fully reversible within: 17 d

Irritation scores

Corneal opacity
Animal Observation time
1 hour 24 hours 48 hours 72 hours 7 days 17 days
4 2 2 3 3 3 3
5 2 2 3 3 4 4
6 2 2 3 2 4 4
Mean 2.00 2.00 3.00 2.67 3.67 3.67

Iris
Animal Observation time
1 hour 24 hours 48 hours 72 hours 7 days 17 days
4 1 1 1 1 2 2
5 1 1 2 2 2 2
6 1 1 1 2 2 2
Mean 1.00 1.00 1.33 1.67 2.00 2.00

Conjunctiva redness
Animal Observation time
1 hour 24 hours 48 hours 72 hours 7 days 17 days
4 2 3 2 2 2 2
5 3 3 3 3 3 3
6 3 3 3 3 2 2
Mean 2.67 3.00 2.67 2.67 2.33 2.33

Chemosis
Animal Observation time
1 hour 24 hours 48 hours 72 hours 7 days 17 days
4 2 3 2 2 2 2
5 3 3 3 3 4 4
6 3 3 3 3 2 2
Mean 2.67 3.00 2.67 2.67 2.67 2.67

Observations other than skin reactions:

The body weight development was not affected by the application of the test article.

No other reactions to treatment were recorded during the whole observation period.

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
FAT 31016/I was considered to be an eye irritant.
Executive summary:

The eye irritation potential of FAT 31016/I was evaluated as per OECD Guideline 405. The test was performed on 3 female rabbits. 0.1 g test substance was placed into the conjunctival sac of the right eye of the rabbits. The left eye was not treated and served as an untreated control. The eye irritation was appraised after 1 hour and on Days 1, 2, 3, 7 and 17 and was scored for each individual rabbit. Insertion of the substance in the eye did lead to irritation. The mean scores (24, 48 and 72 hours) for corneal opacity, iris, conjunctival redness and chemosis were calculated to be 2.6, 1.33, 2.78 and 2.78 respectively. The individual scores were found to meet the criteria of classification as per CLP (Regulation EC No. 1272/2008). Further, the reactions were not reversible within 17 days. Hence, FAT 31016/I should be considered to be an eye irritant and should be classified in category 2, 'irritating to eyes'.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation:

The skin irritation potential of FAT 31016/I was evaluated in a study conducted according to OECD Guideline 404. 3 male rabbits were used in this study. A gauze patch with 0.5 g of the test material was applied to the prepared skin of the rabbits for the exposure duration of 4 hours. The reactions of the skin were appraised upon removal during an observation period of 7 days. The sum of scores read after 1, 24, 48 and 72 hours for erythema and edema were summed up and divided by 12 to get the primary irritation index, which was calculated to be 3.33. The mean individual scores for erythema as well as edema (mean of scores recorded at 24, 48 and 72 hours) for all 3 animals were 1.67 each. Hence, the criteria of "mean value of ≥ 2.3 - ≤ 4.0 for erythema/eschar or for oedema in at least 2 of 3 tested animals from gradings at 24, 48 and 72 hours", required for classification of the substance as irritant was not attained. However, till the end of observations (day 7), erythema as well as edema were found to be persistent. Hence taking a conservative approach, owing to the lack of details regarding the reversibility of skin reactions, the substance was concluded to be an irritant to the skin.

Eye irritation:

The eye irritation potential of FAT 31016/I was evaluated in a study conducted accroding to OECD Guideline 405. The test was performed on 3 female rabbits. 0.1 g test substance was placed into the conjunctival sac of the right eye of the rabbits. The left eye was not treated and served as an untreated control. The eye irritation was appraised after 1 hour and on Days 1, 2, 3, 7 and 17 and was scored for each individual rabbit. Insertion of the substance in the eye did lead to irritation. The mean scores (24, 48 and 72 hours) for corneal opacity, iris, conjunctival redness and chemosis were calculated to be 2.6, 1.33, 2.78 and 2.78 respectively. The individual scores were found to meet the criteria of classification as per CLP (Regulation EC No. 1272/2008). Further, the reactions were not reversible within 17 days. Hence, FAT 31016/I should be considered to be an eye irritant and should be classified in category 2, 'irritating to eyes'.

Justification for classification or non-classification

As discussed above, the substance can cause skin as well as eye irritation, hence should be classified as skin irritant cat 2 and eye irritant cat 2, as per the Regulation (EC) No. 1272/2008 (CLP) criteria.