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Description of key information

Skin: The reaction mass of 4-sulphophthalic acid and 3-sulphophthalic acid (3:1 ratio) was determined to be compatible with the Corrositex® system. Then, a formulation of 10% test material in water 100 uL (test material: 900 uL tissue culture water) was categorized by pH to determine Category 1 cut-off times to determine corrosivity. 0.5 mL of the test article was added to each of four Corrositex® test vials containing biobarriers and the times required for the test article to permeate or destroy the biobarriers were recorded. A positive control (1.0 N sodium hydroxide) and a negative control (1% citric acid) were tested concurrently. The average breakthrough time for the four test material samples was 12.26 minutes. The test material was considered moderately corrosive (Category 1B).

Eye: To determine the potential for ocular irritation using an alternative to the Draize methodology, a study based on the methodology described in the current OECD Guideline for the Testing of Chemicals No. 437 was conducted. Three bovine corneas per group were dosed with 0.75 ml of reaction mass of 4-sulphophthalic acid and 3-sulphophthalic acid (3:1 ratio), Minimal Essential Media (MEM, negative control), or 100% ethanol (positive control). Following a 10-minute exposure for each group of dosed corneas, opacity measurements and sodium fluorescein permeability were determined. The MEM solution is then removed from the anterior chamber and replaced with 1.0 ml of 0.4% sodium fluorescein solution. After 90 min the fluid from the posterior chamber is removed and the amount of dye that passed through the cornea is measured as the optical density at 490 nm by a plate reader. For the test substance, the in vitro irritancy score (IVIS) is 162.35, corneal opacity score is 158.00, and the permeability score is 0.290. Based on an IVIS of greater than 55, and as defined in OECD Guideline No. 437, the reaction mass of 4-sulphophthalic acid and 3-sulphophthalic acid (3:1 ratio) was determined to be GHS Category 1 and was considered a severe/corrosive eye irritant.


Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin corrosion: in vitro / ex vivo
Remarks:
in vitro
Type of information:
experimental study
Adequacy of study:
key study
Study period:
24 feb 2017 to 03 May 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)
GLP compliance:
yes (incl. certificate)
Test system:
artificial membrane barrier model
Remarks:
Reconstituted collagen matrix, constructed to have physico-chemical properties similar to rat skin
Source species:
other: Reconstituted collagen matrix, constructed to have physico-chemical properties similar to rat skin
Vehicle:
unchanged (no vehicle)
Species:
other: Reconstituted collagen matrix, constructed to have physico-chemical properties similar to rat skin
Type of coverage:
other: In vitro
Vehicle:
unchanged (no vehicle)
Duration of treatment / exposure:
Single Exposure
Irritation / corrosion parameter:
penetration time (in minutes)
Run / experiment:
1
Value:
ca. 12.26
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
positive indication of irritation

The positive control, 1.0 N Sodium Hydroxide, was categorized as received and the negative control, Citric Acid, was used as a 10% solution in water. The results of both controls were considered valid.

Interpretation of results:
Category 1B (corrosive) based on GHS criteria
Remarks:
Criteria used for interpretation of results: OECD GHS
Conclusions:
The material was considered moderately corrosive. The material was classified in Packing Group II of GHS Subcategory 1B.
Executive summary:

The reaction mass of 4- Sulphophthalic acid (CAS 89 -08 -7) and 3- sulphophthalic acid (CAS 67892 -43 -7), 3:1 ratio was determined to be compatible with the Corrositex® system. Then, a formulation of 10% test material in water 100 uL test material : 900 uL tissue culture water) was categorized by pH to determine Category 1 cut-off times should be used to determine corrosivity. 0.5 mL of the test article was added to each of four Corrositex® test vials containing biobarriers and the times required for the test article to permeate or destroy the biobarriers were recorded. A positive control (1.0 N sodium hydroxide) and a negative control (1% citric acid) was tested concurrently. The average breakthrough time for the four test material samples was 12.26 minutes. The test material was considered moderately corrosive.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vitro / ex vivo
Remarks:
in vitro
Type of information:
experimental study
Adequacy of study:
key study
Study period:
23 Feb 2017 to 03 May 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
GLP compliance:
yes (incl. certificate)
Species:
cattle
Strain:
not specified
Remarks:
bovine cornea
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent positive control
yes, concurrent negative control
Amount / concentration applied:
100ml of a 10X solution
Duration of treatment / exposure:
single exposure/ one day
Irritation parameter:
cornea opacity score
Value:
158
Vehicle controls validity:
valid
Negative controls validity:
valid
Remarks:
Minimal Essential Media
Positive controls validity:
valid
Remarks:
100% Ethanol
Remarks on result:
positive indication of irritation
Remarks:
Severe/corrosive eye irritant
Irritation parameter:
in vitro irritation score
Value:
162.35
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
positive indication of irritation
Irritation parameter:
fluorescein leakage
Value:
0.29
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
positive indication of irritation

The positive control, 100 % ethanol, was categorized and received and the negative control, Minimal Essential Material (MEM), was used as a 10% solution in 0.9% saline.

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Remarks:
Severe/corrosive eye irritant
Conclusions:
The material was considered a severe/corrosive eye irritant. The material was classified in Category 1.
Executive summary:

To determine the potential for ocular irritation using an alternative to the Draize methodology, a study based on the methodology described in the current OECD Guideline for the Testing of Chemicals No. 437 was conducted. Three bovine corneas per group were dosed with 0.75 ml of Reaction Mass of 4- sulphophthalic acid (CAS 89-08-7) and 3-sulphophthalic acid (CAS 67892-43-7), 3:1 ratio, Minimal Essential Media (MEM, negative control), or 100% ethanol (positive control). Following a 10-minute exposure for each group of dosed corneas, opacity measurements and sodium fluorescein permeability were determined. The MEM solution is then removed from the anterior chamber and replaced with 1.0 ml of 0.4% sodium fluorescein solution. After 90 min the fluid from the posterior chamber is removed and the amount of dye that passed through the cornea is measured as the optical density at 490 nm by a plate reader. For the test substance, the in vitro irritancy score (IVIS) is 162.35, corneal opacity score is 158.00, and the permeability score is 0.290. Based on an IVIS of greater than 55, and as defined in OECD Guideline No. 437, the reaction mass of sulphophthalic acid was determined to be GHS Category 1 and was considered a severe/corrosive eye irritant.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Skin Hazard Classification: The average breakthrough time for the four test material samples was 12.26 minutes. The test material was considered moderately corrosive (Category 1B).

Eye Hazard Classification: The corneal opacity score is 158 and the permeability score is 0.290. The test material was defined into Category 1 and was considered a severe/corrosive eye irritant.