6-[[(4-methylphenyl)sulphonyl]amino]hexanoic acid

Endpoint summary

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

Remarks:

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.

Justification for type of information:

Study was performed in 2000 according to OECD guideline 404, before REACH Regulation came into force. The available data is reliable without restriction and was used in order to meet the information requirements.

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

, 17. July 1992

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Version / remarks:

August 1998

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system 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 edema 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.

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other:

Remarks:

not possible because no changes occurred

Remarks on result:

other:

Remarks:

There were no signs of redness or swelling at all time points.

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other:

Remarks:

not possible because no changes occurred

Remarks on result:

other:

Remarks:

There were no signs of redness or swelling at all time points.

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other:

Remarks:

not possible because no changes occurred

Remarks on result:

other:

Remarks:

There were no signs of redness or swelling at all time points.

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other:

Remarks:

not possible because no changes occurred

Remarks on result:

other:

Remarks:

There were no signs of redness or swelling at all time points.

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other:

Remarks:

not possible because no changes occurred

Remarks on result:

other:

Remarks:

There were no signs of redness or swelling at all time points.

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other:

Remarks:

not possible because no changes occurred

Remarks on result:

other:

Remarks:

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.

Justification for type of information:

Study was performed in 2001 according to OPPTS 870.2400, before REACH Regulation came into force. The available data is reliable without restriction and was used in order to meet the information requirements.

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: 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

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other:

Remarks:

not possible because no change (corneal opacity) occurred

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other:

Remarks:

not possible because no change (corneal opacity) occurred

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other:

Remarks:

not possible because no change (corneal opacity) occurred

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other:

Remarks:

not possible because no change occurred

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other:

Remarks:

not possible because no change occurred

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other:

Remarks:

not possible because no change occurred

Irritation parameter:

conjunctivae score

Remarks:

conjunctiva redness

Basis:

animal #1

Time point:

24 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 72 h

Irritation parameter:

conjunctivae score

Remarks:

conjunctiva redness

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

1

Reversibility:

fully reversible

Remarks:

conjunctival irritation at 1 h post dose which cleared within 24 hours

Irritation parameter:

conjunctivae score

Remarks:

conjunctiva redness

Basis:

animal #3

Time point:

24 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 72 h

Irritation parameter:

chemosis score

Remarks:

Conjunctiva chemosis

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other:

Remarks:

not possible because no change occurred

Irritation parameter:

chemosis score

Remarks:

Conjunctiva chemosis

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

1

Reversibility:

fully reversible within: 24 h

Remarks:

chemosis at 1 h post dose which was reversible within 24 hours

Irritation parameter:

chemosis score

Remarks:

Conjunctiva chemosis

Basis:

animal #3

Time point:

24 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 48 h

Remarks:

chemosis at 1 h and 24 h post dose which was reversible within 48 hours

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 a 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.