Registration Dossier

Administrative data

Description of key information

The substance was not irritating to skin and eyes in rabbits.

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.
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)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan, Horst, The Netherlands
- Age at study initiation: at least 6 weeks
- Weight at study initiation: at least 1.0 kg
- Housing: individually in labelled cages with perforated floors (Scanbur, Denmark, dimensions 56x44x37.5 cm)
- Diet: Pelleted diet for rabbits (K-H from SSNIFF® Spezialdiäten GmbH, Soest, Germany) approximately 100 grams per day. Hay (Technilab-BMI BV, Someren The Netherlands) was provided at least 3 times a week
- Water: free access to tap water
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.4-22.5
- Humidity (%): 39-64
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12 / 12
Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: adjacent areas of the untreated skin of each animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
up to 72 hours
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: 150 cm2
- Type of wrap if used: metalline patch of 2x3 cm, mounted on Micropore tape, which was wrapped around the abdomen and secured with Coban elastic bandage

REMOVAL OF TEST SUBSTANCE
- Washing: yes, using tap water
- Time after start of exposure: 4 hours

SCORING SYSTEM: according to OECD guideline 404
Irritation parameter:
edema score
Basis:
animal: 1 to 3
Time point:
other: 1h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
animal: 1 to 3
Time point:
other: 1h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
animal: 1 to 3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal: 1 to 3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Other effects:
No staining of the treated skin by the test substance was observed and no test substance remnants were seen. No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Interpretation of results:
GHS criteria not met
Conclusions:
There was no evidence of skin irritation or corrosion, no staining of the treated skin, and no symptoms of systemic toxicity were observed after 4 hrs of exposure to AC-6000. Therefore, AC-6000 is not considered irritating/corrosive for the skin.
Executive summary:

An acute dermal irritation GLP study according to OECD guideline 404 was conducted in 3 male New Zealand White rabbits in order to evaluate the irritation and corrosion effects of AC-6000 on the skin. In this study 0.5 mL of the test substance was applied to the clipped skin of rabbits for 4 hours using a semi-occlusive dressing. Skin reactions were assessed 1, 24, 48 and 72 hours after exposure. No skin irritation was caused by 4 hours exposure to AC-6000. The mean (24, 48 and 72 hours) scores for erythema and edema were both 0. Based on these results AC-6000 can be regarded as not irritating to 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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Harlan, Horst, The Netherlands
- Age at study initiation: at least 6 weeks
- Weight at study initiation: at least 1.0 kg
- Housing: individually in labelled cages with perforated floors (Scanbur, Denmark, dimensions 56x44x37.5 cm)
- Diet: Pelleted diet for rabbits (K-H from SSNIFF® Spezialdiäten GmbH, Soest, Germany) approximately 100 grams per day. Hay (Technilab-BMI BV, Someren, The Netherlands) was provided at least 3 times a week
- Water: free access to tap water
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.4-24
- Humidity (%): 44-66
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12 / 12
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 mL
Duration of treatment / exposure:
single application
Observation period (in vivo):
up to 72 hours
Number of animals or in vitro replicates:
3 males
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: no

SCORING SYSTEM: according to OECD guideline 405

TOOL USED TO ASSESS SCORE: hand-slit lamp / fluorescein
Irritation parameter:
chemosis score
Basis:
animal: 1 to 3
Time point:
other: 1h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal: 1 to 3
Time point:
other: 1h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal: 1 to 3
Time point:
other: 1h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
animal: 1 to 3
Time point:
other: 1h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
animal: 1 to 3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal: 1 to 3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal: 1 to 3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
animal: 1 to 3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Other effects:
No staining of (peri) ocular tissues by the test substance was observed and no test substance remnants were seen. No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Interpretation of results:
GHS criteria not met
Conclusions:
There was no evidence of ocular irritation or corrosion, no staining of the (peri) ocular tissues, and no symptoms of systemic toxicity were observed after instillation of AC-6000 to the eye. Therefore, AC-6000 is not considered irritating/corrosive for the eyes.
Executive summary:

An acute eye irritation GLP study according to OECD guideline 405 was conducted in three male New Zealand White rabbits in order to evaluate the irritation and corrosion effects of AC-6000 on the eyes. In this study 0.1 mL of the test substance was applied to the left eye of the rabbits. No washing was performed. Observations were made 1, 24, 48 and 72 hours after instillation. No irritation of the ocular tissues was noted after instillation of AC-6000. The mean (24, 48 and 72 hours) cornea, iris, conjunctivae and chemosis scores were all 0. Based on these results AC-6000 can be regarded as not irritating to the eyes.

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

Additional information

Skin irritation

An acute dermal irritation GLP study according to OECD guideline 404 was conducted in 3 male New Zealand White rabbits in order to evaluate the irritation and corrosion effects of AC-6000 on the skin (NOTOX B.V., 2007). In this study 0.5 mL of the test substance was applied to the clipped skin of rabbits for 4 hours using a semi-occlusive dressing. Skin reactions were assessed 1, 24, 48 and 72 hours after exposure. No skin irritation was caused by 4 hours exposure to AC-6000. The mean (24, 48 and 72 hours) scores for erythema and edema were both 0. Based on these results AC-6000 can be regarded as not irritating to skin.

 

Eye irritation

An acute eye irritation GLP study according to OECD guideline 405 was conducted in three male New Zealand White rabbits in order to evaluate the irritation and corrosion effects of AC-6000 on the eyes (NOTOX B.V., 2007). In this study 0.1 mL of the test substance was applied to the left eye of the rabbits. No washing was performed. Observations were made 1, 24, 48 and 72 hours after instillation. No irritation of the ocular tissues was noted after instillation of AC-6000. The mean (24, 48 and 72 hours) cornea, iris, conjunctivae and chemosis scores were all 0. Based on these results AC-6000 can be regarded as not irritating to the eyes.

Justification for classification or non-classification

Based on the results of the skin and eye irritation studies, classification according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 is not needed.