Registration Dossier

Administrative data

Description of key information

skin irritation, rabbits (m/f), intact skin, not irritating
eye irritation, rabbits (m/f), washed and unwashed eye, not irritating

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
other: read across from analogue substance
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Guideline:
other: Proposed Guidelines of the United States Environmental Agency (EPA) § 163.81- 5 "Primary dermal irritation study", Federal Register, Vol. 43, No. 163, August 22, 1978
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Adult New Zealand White rabbits bred and raised on the premises weighing 2 to 3 kgs. They were housed individually in metal cages, numbered by ear tags, were kept at a constant room temperature of 22 +/- 2° C, at a relative humidity of 55 +/- 10 % and on a 10 hours light cycle day. The animals received ad libitum standard rabbit food - NAFAG, No. 814, Gossau SG - and water. Prior to treatment they were adapted to our laboratories for a minimum of 4 days.
Type of coverage:
not specified
Preparation of test site:
other: shaved, one side intact and one side abraded
Vehicle:
other: propylene glycol + saline (70 : 30 parts)
Amount / concentration applied:
0.5g of test item, 50% in the vehicle
Duration of treatment / exposure:
24h
Observation period:
7 days
Number of animals:
3 males and 3 females
Details on study design:
Before treatment the entire back and the flank of the rabbits were shaved with an electric clipper and immediately before treatment the shaven skin on one side was slightly scarified with the help of a "SchröpfSchnäpper", Aesculap, Switzerland. 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. The patches were covered with an impermeable material and were fastened to the body of the rabbit with adhesive tape. The dressings were removed after a 24 hour application. The skin reaction was appraised upon removal and duringan observation period of 7 days.
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
intact skin
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
intact skin
Time point:
24/48/72 h
Score:
ca. 0.67
Max. score:
1
Reversibility:
fully reversible within: 72h
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
intact skin
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #4
Remarks:
intact skin
Time point:
24/48/72 h
Score:
ca. 0.3
Max. score:
1
Reversibility:
fully reversible within: 72h
Irritation parameter:
erythema score
Basis:
animal #5
Remarks:
intact skin
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #6
Remarks:
intact skin
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
intact skin
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
intact skin
Time point:
24/48/72 h
Score:
ca. 0.67
Max. score:
1
Reversibility:
fully reversible within: 72h
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
intact skin
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #4
Remarks:
intact skin
Time point:
24/48/72 h
Score:
ca. 0.3
Max. score:
1
Reversibility:
fully reversible within: 72h
Irritation parameter:
edema score
Basis:
animal #5
Remarks:
intact skin
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #6
Remarks:
intact skin
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Irritant / corrosive response data:
results on the abraded skin are also available, and the maximum mean value is 1, fully reversible within 72h. They were not inserted since the Regulation 1272/2008 does not take into account results on scarified skin for the skin irritation evaluation
Interpretation of results:
other: not classified under Rehulation 1272/2008
Conclusions:
The test item was tested for skin irritation potential. Under the experimental conditions the test item did not show skin irritation properties.
Executive summary:

The test item was tested for skin irritation potential. A group of three males and females NZW rabbits were tested on shaved intact and abraded skin by a 24h exposure to the test item and readings were performed at 24h, 48 and 72h, 4 and 7 days for edema and erythema. Mean values over 24, 48 and 72h were used for assessing he skin irritation potential. Under the experimental conditions the tes item is not considered a skin 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:
other: read across from analogue substance
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: Proposed Guidelines of the United States Environmental Protection Agency (EPA) § 163.81-4 "Primary eye irritation study", Federal Register, Vol. 43, No. 163, August 22, 1978.
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
The test was performed on 3 male and 3 female adult New Zealand White rabbits bred and raised on the premises weighing 2 to 3 kgs. The animals were housed individually in metal cages, numbered by ear tags, were kept at a constant room temperature of 22 + 2° C, at a relative humidity of 55+10 % and on a 10 hour light cycle day.The animals had ad libitum access to standard rabbit food - NAFAG, No. 814, Gossau SG - and water. Prior to treatment they were adapted to our laboratories for a minimum of 4 days. Only rabbits with normal ophthalmic findings were used for these tests
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye
Amount / concentration applied:
0.1g
Duration of treatment / exposure:
few seconds
Observation period (in vivo):
24h, 48h, 72h, 4 and 7 days
Number of animals or in vitro replicates:
3 males and 3 females
Details on study design:
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
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Irritation parameter:
conjunctivae score
Remarks:
chemosis, redness and discharge
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Irritation parameter:
conjunctivae score
Remarks:
chemosis, redness and discharge
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Irritation parameter:
conjunctivae score
Remarks:
chemosis, redness and discharge
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Irritation parameter:
conjunctivae score
Remarks:
chemosis, redness and discharge
Basis:
animal #4
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Irritation parameter:
conjunctivae score
Remarks:
chemosis, redness and discharge
Basis:
animal #5
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Irritation parameter:
conjunctivae score
Remarks:
chemosis, redness and discharge
Basis:
animal #6
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Interpretation of results:
other: not classified under Regulation 1272/2008
Conclusions:
The test item was teted for eye irritation potential. Under the experimental conditions the item did not show any eye irritative properties.
Executive summary:

The test item was teted for eye irritation potential. The left eye of three males and three females of NZW rabbits were exposed for a few seconds to the test item, and three of them were rinsed with physiological saline solution. The right eye was left untreated and served as control. The cornea, iris and conjuncitvae scores were determined at 24, 48, 72h, 4 and 7 days and resulted equal to zero. Under the experimental conditions the tested item is not considered as irritant to the eye.

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

Additional information

One study was performed to assess the skin irritation potential of the analogue test item (Huntsman 1980). Males and females of NZW rabbits were exposed to the test item and the mean values for edema and erythema over 24,48 and 72h observation period were recorded. Under the experimental conditions the test item is not considered as a skin irritant.

One study was performed to assess the eye irritation potentail of the analogue test item (Huntsman, 1980).

Males and females of NZW rabbits were exposed to the test item and the mean values for cornea, iris and conjunctivae over 24,48 and 72h observation period were recorded. Under the experimental conditions the test item is not considered as an eye irritant.

Based on the read across considerations the same results apply to Acid Black 107:1

Justification for classification or non-classification

Under Regulation 1272/2008 a substance is classified as skin irritant Cat. 2 if:

1) 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 after patch removal or, if reactions are delayed, from grades on 3 consecutive days after the onset of skin reactions; or

2)Inflammation that persists to the end of the observation period normally 14 days in at least 2 animals, particularly taking into account alopecia (limited area), hyperkeratosis, hyperplasia, and scaling; or

3) In some cases where there is pronounced variability of response among animals, with very definite positive effects related to chemical exposure in a single animal but less than the criteria above.

Mean values at 24, 48 and 72h for oedema or erythema are <2 for all animals and are completely reversible within 72h, therefore the test substance is not classified as skin irritant.

Under Regulation 1272/2008 a substance is classified as eye irritant Cat. 2 if it is present at least in 2 of 3 tested animals, a positive response of: 1)    corneal opacity ≥ 1 and/or 2)   iritis ≥ 1, and/or 3)  conjunctival redness ≥ 2 and/or 4)  conjunctival oedema (chemosis) ≥ 2 calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material, and which fully reverses within an observation period of 21 days.

All the scores calculated as mean value at 24, 48 and 72h for the test substances for all tested animals are equal to zero, therefore the substance is not classified as eye irritant.