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Diss Factsheets

Administrative data

Description of key information

Based on two in-vivo studies Acid Violet 109 is not irritating to skin or 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:
1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: EN.Nr. 400047.32
- Expiration date of the lot/batch: December 1998

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature (ca. 20 °C) away from direct sunlight.
- Stability under test conditions: Stable at storage conditions
- Stability of the test substance in the solvent/vehicle: Up to 24 hours bidistilled water
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Birkendorferstrasse 65,D-88397 Biberach/Riss
- Age at study initiation:15 weeks
- Housing: Placed Individually in stainless steel cages with an automatic cleaning system equipped with feed hoppers, drinking water bowls and wood for gnawing.
- Diet : Pelleted standard Kliba 341 rabbit maintenance diet ad libitum (batch no.75/97)
- Water: Community tap water from Itingen, ad libitum, in water bowls.
- Acclimation period: Four days under test conditions after health examination.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): 40-70 %
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle.
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
not specified
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): As a solid, approximately 0.5 g (per animal) of the test article was weighed and then moistened with bidistilled water before application.
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
1 male and 2 females
Details on study design:
Preparation:
Approximately 24 hours before treatment, the dorsal fur was clipped with an electric clipper, exposing an area of approximately 100 cm2 (10 cm x 10 cm) and the skin of the animals was examined.

TEST SITE
- Area of exposure: On the day of treatment, the test article was applied to approximately 6 cm2 of the intact skin of the clipped area.
- Type of wrap if used: It was covered with a 2.5 cm x 2.5 cm patch of surgical gauze and the gauze was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the dressing was removed and the skin was flushed with lukewarm tap water

SCORING SYSTEM:
The skin reaction was assessed according to the numerical scoring system listed in the EEC Commission Directive 92/69/EEC, July 31, 1992 at approximately 1, 24, 48 and 72 hours after the removal of the dressing, gauze patch and test article.
If evident, corrosive or staining properties of the test article were described and recorded.
Irritation parameter:
erythema score
Basis:
mean
Remarks:
Animal No 7, 8 and 9
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Remarks:
Animal No 7, 8 and 9
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Application of the test article to healthy intact rabbit skin resulted in a primary irritation score of 0.00. Local signs (mean values from 24 to 72 hours) consisted of grade 0.00 erythema and grade 0.00 edema. No irreversible alterations of the treated skin were observed nor were corrosive effects evident on the skin.
Other effects:
VIABILITY/MORTALITY AND CLINICAL SIGNS
No clinical signs of systemic toxicity were observed

BODY WEIGHTS
The body weight of all rabbits were considered to be within the normal range of variability.
Interpretation of results:
GHS criteria not met
Conclusions:
FAT 21016/C is considered to be "not irritating" to rabbit skin.
Executive summary:

The primary skin irritation potential of the test article was investigated by topical application of 0.5 g to 6 cm² intact dorsal skin of each of three young adult New Zealand rabbits according to OECD 404 and EU B4 guidelines. The scoring of skin reactions was performed 1, 24, 48 and 72 h after removal of the dressing. The scores of each animal at the following reading times (24, 48, 72 h) were used in calculating the respective mean values for erythema and edema. The primary irritation score was calculated by totalling the individual cumulative scores at 24, 48 and 72 h and then dividing by the number of figures. The primary irritation score was 0.00 (max. 8.0). Local signs (mean values from 24 to 72 h) consisted of grade 0.00 erythema and grade 0.00 edema. The test article caused violet or light violet staining of the treated skin. No irritating or corrosive effects were noted on the exposed skin of any animal at any measuring interval. Hence, FAT 21016/C is considered to be "not irritating" to rabbit 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:
1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
July 31, 1992
Deviations:
no
GLP compliance:
yes
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: EN. Nr. 400047.32
- Expiration date of the lot/batch: December 1998

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature (ca. 20 °C) away from direct sunlight
- Stability of the test substance in the solvent/vehicle: Stable at storage conditions
Species:
rabbit
Strain:
New Zealand White
Remarks:
Chbb:NZW(SPF)
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Birkendorferstrasse 65, D-88397 Biberach/Riss
- Age at study initiation: 15 weeks
- Housing: Individually in stainless steel cages with an automatic cleaning system equipped with feed hoppers, drinking water bowls and wood for gnawing.
- Diet: ad libitum
- Water: ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light):12/12

Vehicle:
unchanged (no vehicle)
Controls:
other: Untreated right eye served as a control
Amount / concentration applied:
TEST MATERIAL
100 mg of the test compound were instilled into the conjunctival sac of the left eye.
Observation period (in vivo):
72 hrs
Number of animals or in vitro replicates:
3 rabbits (1 male and 2 female)
Details on study design:
SCORING SYSTEM:
The ocular reaction was assessed according to the numerical scoring system listed in the EEC Commission Directive 92/69/EEC, July 31, 1992

TOOL USED TO ASSESS SCORE: Eye examinations were made with a Varta Cliptrix diagnostic-lamp (A. Riegger, Basel / Switzerland).
Irritation parameter:
cornea opacity score
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
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:
redness
Basis:
mean
Remarks:
3 animals
Time point:
24/48/72 h
Score:
0.22
Max. score:
3
Reversibility:
fully reversible within: 48h
Irritation parameter:
chemosis 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:
Application of the test article to healthy rabbit conjunctivae resulted in a primary irritation score of 0.22. Slight reddening and slight swelling of the conjunctivae, as well as slight to moderate watery discharge and hyperemia of the scleral blood vessels were observed. All findings were reversible after 48 hours. A corneal reaction consisting of damage to the superficial epithelium was seen in one unwashed eye (NC.12) at 24 hours only. Staining of the conjunctivae by the compound was noted in all unwashed eyes up to 72 hours.
Other effects:
VIABILITY/MORTALITY AND CLINICAL SIGNS: No clinical signs of systemic toxicity were observed in the animals during the test and observation period, and no mortality occurred
COLORATION: No staining of the cornea, sclera or conjunctivae by the test article was observed.
CORROSION: No corrosion of the cornea was observed at any of the reading times.
BODY WEIGHTS: The body weight of all rabbits were considered to be within the normal range of variability.

Body weights:

 Animal Nr  Sex  First day of Acclimatisation  First day of treatment  Last day of Observation
 19  Male  2842  3030  3102
 20  Female  3035  3330  3392
 21  Female  2942  3179  3259
Interpretation of results:
GHS criteria not met
Conclusions:
FAT 21016/C is considered to be "not irritating" to the eye.
Executive summary:

FAT 21016/A was subjected to eye irritation test accrding to following guidelines: Directive 92/69 EEC, B.5 and OECD 405 guideline and in accordance to GLP. The primary irritation potential of the test article was investigated by instillation of 0.1 g into one eye of each of three young adult New Zealand rabbits. The treated eyes were not rinsed after application. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours after test article application. The scores of each animal at the following reading times (24, 48 and 72 hours) were used in calculating the respective mean values for each type of lesion. The primary irritation score was calculated by totalling the individual cumulative scores at 24, 48 and 72 hours and then dividing the resulting total by the number of figures. The primary irritation score was 0.22 (max. 13). Reddening and swelling of the conjunctivae as well as watery discharge and hyperemia of the scleral blood vessels were observed. However these findings were reversible after 48 hours. Cornea and iris were not affected throghout the study. No staining of the cornea, sclera or conjunctivae of the treated eyes by the test article was observed. No corrosion was observed at any of the measuring intervals. In conclusion, FAT 21016/C is considered to be "not irritating" 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 potential of Acid Violet 109 was assesed in several in vivo studies.In a study conducted with FAT 21016/C (1997), considered as key study, three rabbits were assessed according to OECD Guideline 404. No irritating or corrosive effects were noted on the exposed skin of any animal at any measuring interval. Hence, FAT 21016/C is considered to be "not irritating" to rabbit skin. The above outcome was also supported by the findings of the studies conducted with FAT 21016/A (1975) and FAT 20200/A (1978).

Eye irritation:

The eye irritation potential of Acid Volet 109 was assesed in several in vivo studies. In the study conducted with FAT 21016/C (1997), considered as key study, three rabbits were assessed

according to OECD Guideline 404. The primary irritation score was 0.22 (max. 13). Reddening and swelling of the conjunctivae as well as watery discharge and hyperemia of the scleral blood vessels were observed. However, these findings were reversible after 48 hours. Cornea and iris were not affected throghout the study. No staining of the cornea, sclera or conjunctivae of the treated eyes by the test article was observed. No corrosion was observed at any of the measuring intervals. In conclusion, FAT 21016/C is considered to be "not irritating" to the eye. The above outcome was also supported by the findings of the studies conducted with FAT 21016/A (1975) and FAT 20200/A (1978).

Justification for classification or non-classification

Acid Violet 109 was found to be not irritating to skin and eyes of rabbits, hence it does not need to be classified according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.