Registration Dossier

Administrative data

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.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2001

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Label identity: OS # 160756 Lot # BECROSAN 2128.5
Supplied by: The Lubrizol Corporation
Date Received: 02/23/2001
Physical state: white powder
Storage: room temperature and humidity

Based on the Certificate of analysis of April 11, 2012:
- Becrosan 2128.5 = 6-[[(4-Methylphenyl)sulfonyl]amino]hexanoic acid (CAS 78521-39-8, EC 278-934-5)
- Solids: 73.0 - 78.0 %
- Water: 22.0 - 27.0 %
- Appearance: White to light yellow powder

Equivilant to ASC plus (based on chemical analysis in 2012).

The substance registered does not contain water as per definition solvent such as water do not belong to the substance (Art. 3 (1), REACH-Regulation). However the test article represents the only marketed form of the substance with ca. 22 - 27 % water. 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.

Test animals / tissue source

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

Test system

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.

Results and discussion

In vivo

Results
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.

Applicant's summary and conclusion

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.