Registration Dossier

Administrative data

Description of key information

ASC plus is regarded as not irritating to eyes and skin based on available studies. Based on the available eye/ mucous membrane irritation study on Rabbits it is likely that the substance has no irritation potential to the mucous membrane of the respiratory tract.

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:
22. August - 13. October 2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well documented study according to OECD guideline under GLP.
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
, 17. July 1992
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Version / remarks:
August 1998
GLP compliance:
yes (incl. certificate)
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: E. A. Prinzhorn, Germany
- Age at study initiation: no data
- Weight at study initiation: 3.27 (female), 3.63 and 3.73 (male)
- Housing: individual in cages
- Diet: Harlan Teklad TLM Rabbit Maintenace Diet (ad libitum)
- Water: drinking water ad libitum
- Acclimation period: more than 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +- 3°C
- Humidity (%): 30-70
- Air changes (per hr): 16
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Preparation of test site:
other: back was clipped
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 3 patches with each containing 0.5 g of undiluted test material were applied onto different areas of the back.

Control: one untreated area on the back
Duration of treatment / exposure:
Animal No. 1:
3 min, 1 h, 4 h
Animals No 2 and 3 were additionally exposed each for 4 h because no treatment related effects were observed for animal No 1.
Observation period:
skin was examined for signs of erythema and oedema according to the classification system of guideline OECD 404 at 1, 24, 48 and 72 h after patch removal.
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: back
- % coverage:
- Type of wrap if used: Gaze-patches, Semiocclusive bandage with Ypsiplast (Holthaus Medical, Remscheid-Lüttringhausen), Elastoplast (Beiersdorf), Stülpa (Beiersdorf)

- skin was examined for signs of erythema and oedema
- clinical signs were examined as well.
Irritation parameter:
erythema score
Remarks:
and oedema score
Basis:
mean
Time point:
other: 1, 24, 48, 72 hours
Score:
0
Max. score:
0
Reversibility:
other: not possible because no changes occured
Remarks on result:
other: There were no signs of redness or swelling at all time points.
Irritant / corrosive response data:
controls: score for erythema and oedema: 0 at all time points, no signs of redness or swelling.

No other toxicological symptoms were observed for treatments and controls.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
fully reliable study,
According to the results of this study: not irritating to skin.
Executive summary:

The test substance (CAS 78521-39-8) was applied to the back of 3 rabbits within a skin irritation test according to guideline OECD 404. 0.5 g of pure undiluted test material were applied in each of 3 patches in a semiocclusive way for 48 hours. Time points for observation were 1, 24, 48 and 72 hours after removal of the patch.

Scores for oedema and erythema: 0 at all time points.

No signs of redness or swelling and no other symptoms.

According to the results of this study the test material is considered 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
Study period:
26. Feb. 2001 to 18. April 2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well documented guideline study under GLP.
Qualifier:
according to
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: Sgarlat's Rabbitry, Harvey's Lake, PA
- Age: Animals were born on 07. & 23. November 2000, received on 31. Jan. & 14. Feb. 2001 and quarantined for at least five days
- Pretest body weight range: 2.0 - 2.5 kg
- Housing: 1 / cage in suspended cages.
- Diet: Fresh Purina Rabbit Chow diet was provided daily ad libitum.
- Water: ad libitum
- Acclimation period: at least 5 days quarantined

ENVIRONMENTAL CONDITIONS
- Temperature (°C): temperature controlled
- Photoperiod (hrs dark / hrs light): 12 hour
Vehicle:
unchanged (no vehicle)
Controls:
other: The contralateral eye served as a control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml (equivilant to 91 mg)
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
at 1, 24, 48, and 72 hours: by the Draize technique
at 24 and 48 hour observation interval: Sodium flourescein dye procedures
Number of animals or in vitro replicates:
-2 males and 1 female free from evidence of ocular irritation and corneal abnormalities were dosed with the test article.
Details on study design:
The test article was placed by syringe into the conjuctival sac. One eye of each rabbit was dosed. The contralateral eye served as a control.
The treated eye of each rabbit was examinded for irritation of the cornea, iris and conjunctiva at 1, 24, 48, and 72 hours postdose.
SCORING SYSTEM: primary eye irritation score for each rabbit, each day was calculated.

TOOL USED TO ASSESS SCORE: fluorescein

Examinations with a Mini-Maglite flashlight equipped with a high intensity bulb.
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72 h
Score:
0
Reversibility:
fully reversible within: 72 h
Irritant / corrosive response data:
There were no corneal opacity or iritis noted at any observation point. Concunctival irritation, noted in 3/3 eyes, cleared by 72 hours.
There were no abnormal systemic signs noted during the observation period.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The ocular application of the test article produced a conjunctival irritation which cleared within 72 hours.
Executive summary:

BECROSAN 2128.5 is the the marketed product containing ca. 75 % 6-[[(4-Methylphenyl)sulfonyl]amino]hexanoic acid (CAS 78521-39-8, EC 278-934-5) and ca. 25 % water. This substance was administered to the eyes of 3 healthy New Zealand White rabbits (2 males - 1 female). 0.1 ml of the test article was placed into the conjunctival sac of on eye of each rabbit. There were no corneal opacity or iritis noted at any observation point (1, 24, 48 and 72 hours post dose). Ocular application of the test article produced a conjunctival irritation which cleared within 72 hours. It is assumed that the same results hold true for the water free substance (as registered). As the water free substance is not marketed the evaluation of the marketed product with respect to eye irritation/ mucous membrane irritation potential is the more relevant in the context of hazard assessment.

Interpretation of results: The test article as well as the water free registered substance 6-[[(4-Methylphenyl)sulfonyl]amino]hexanoic acid) is regarded as not irritating.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for selection of skin irritation / corrosion endpoint:
reliable GLP-Guideline study, key study

Justification for selection of eye irritation endpoint:
reliable GLP-Guideline study, key study

Justification for classification or non-classification

According to the criteria of Regulation (EC) No.: 1272/2008, the substance is not classified with regard to Skin corrosion/Irritation and Serious damage to eyes/eye irritation. Also, according to the criteria specified by Directive 67/548/EEC the substance is not classified with regard to these hazard classes.