3-cyclohexylaminopropane-1-sulphonic acid

Endpoint summary

Description of key information

Skin irritation: Data waiving: The study does not need to be conducted because an acute toxicity study by the dermal route does not indicate skin irritation up to the relevant limit dose level

Eye irritation: In vitro: BCOP, applied unchanged, IVIS < 3, not irritating to the eye (OECD 437, GLP)

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin corrosion: in vitro / ex vivo

Remarks:

and in vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because an acute toxicity study by the dermal route does not indicate skin irritation up to the relevant limit dose level (2 000 mg/kg body weight)

Justification for type of information:

JUSTIFICATION FOR DATA WAIVING
No pathological changes on the treated skin of male and female rats were found in a acute dermal toxicity test at a dose of 2000 mg/kg.

Reason / purpose for cross-reference:

data waiving: supporting information

Endpoint conclusion

Endpoint conclusion:

no study available

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP OECD 437 guideline study without deviations on the registered substance itself

Qualifier:

according to guideline

Guideline:

OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)

Version / remarks:

OECD Guideline No. 437, edition adopted 26. Jul. 2013: “Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage"

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)

Version / remarks:

EU Method B. 47: “Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants” adopted 09. Dec. 2010

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Landesamt für Umwelt, Waserwirtschaft und Gewerbeaufsicht, Kaiser-Friedrich-Straße 7, 55116 Mainz, Germany

Species:

other: Bos primigenius Taurus (fresh bovine corneas)

Strain:

not specified

Details on test animals or tissues and environmental conditions:

not applicable

Vehicle:

unchanged (no vehicle)

Controls:

other: 0.9% NaCl in demin. water (negative control), 20% Imidazole dissolved in 0.9% sodium chloride solution (positive control)

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 250.4 mg, 255.8 mg, or 292.7 mg. The test item was given on the epithelium in such a manner that the cornea was completely covered with test item.

Duration of treatment / exposure:

4 h

Observation period (in vivo):

incubation with fluorescein solution for further 90 min

Number of animals or in vitro replicates:

3 replicate corneas for each treatment group (negative control solution, test item and positive control)

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): thorough rinsing with cMEM with phenol red and final rinsing with cMEM without phenol red
- Time after start of exposure: 4 h

SCORING SYSTEM: Opacity value, calculated from the measured absorbance at 570 nm; permeability of the cornea was measured as optical density of the liquid at 490 nm

TOOL USED TO ASSESS SCORE: fluorescein

Irritation parameter:

in vitro irritation score

Run / experiment:

cornea #1 (test item)

Value:

-0.04

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: IVIS ≤ 3 -> No Category (UN GHS, Eye damage)

Irritation parameter:

in vitro irritation score

Run / experiment:

cornea #2 (test item)

Value:

-0.38

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: IVIS ≤ 3 -> No Category (UN GHS, Eye damage)

Irritation parameter:

in vitro irritation score

Run / experiment:

cornea #3 (test item)

Value:

0.4

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: IVIS ≤ 3 -> No Category (UN GHS, Eye damage)

Irritation parameter:

in vitro irritation score

Run / experiment:

mean over 3 corneas (test item)

Value:

-0.01

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: IVIS ≤ 3 -> No Category (UN GHS, Eye damage)

Other effects / acceptance of results:

In the negative control, no signs of eye irritation were observed (IVIS = 0.89; mean over 3 corneas).
The positive control induced serious eye damage (IVIS = 77.74; mean over 3 corneas), which would be classified as GHS category 1.
The test item 3-(Cyclohexylamino)-propane sulfonic acid showed no effects on the cornea of the bovine eye. The mean calculated IVIS (in vitro irritancy score) is -0.01.

Interpretation of results:

GHS criteria not met

Conclusions:

Testing was performed via a GLP OECD 437 guideline study on the registered substance itself. The present in vitro method is recommended in a tiered testing approach and the validity criteria are met, making the results sufficiently reliable to assess the corrosivity of 3-(Cyclohexylamino)-propane sulfonic acid to the eye. The present in vitro method allows the identification of corrosive chemical substances and mixtures or of substances which do not require classification.
One valid experiment was performed. The test item 3-(Cyclohexylamino)-propane sulfonic acid showed no effects on the cornea of the bovine eye. The calculated IVIS (in vitro irritancy score) is -0.01. The experiment is considered as sufficient for the classification of the test item, because all three replicates of the test item lead to the same assessment for the test item. This single in vitro test can serve as a stand-alone test as it was consistently shown that the test item does not require classification (eye damage).

Executive summary:

In an OECD 437 (in vitro eye corrosion) study under GLP, one valid experiment was performed.

Bovine corneas were used. They were collected from slaughtered cattle which were between 12 and 60 months old.

The test item 3-(Cyclohexylamino)-propane sulfonic acid was brought onto the cornea of a bovine eye which had been incubated with cMEM without phenol red at 32 ± 1 °C for 1 h and whose opacity had been measured. The test item was incubated on the cornea for4 h at32 ± 1 °C. After removal of the test item, opacity and permeability values were measured.

 

Physiological sodium chloride solution was used as negative control. The negative control showed no irritating effect on the cornea and the calculated IVIS (in vitro irritancy score) is 0.89.

20% Imidazole solution was used as positive control. The positive control induced serious eye damage on the cornea and falls within two standard deviations of the current historical mean. The calculated IVIS (in vitro irritancy score) is 77.74.

 

Under the conditions of this study, the test item 3-(Cyclohexylamino)-propane sulfonic acid showed no effects on the cornea of the bovine eye. The calculated IVIS (in vitro irritancy score) is – 0.01.

According to OECD Guideline no. 437 (Jul. 2013), a substance with an IVIS ≤ 3 requires no classification for eye irritation or serious eye damage.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

No pathological changes on the treated skin of male and female rats were found in an acute dermal toxicity test at a dose of 2000 mg/kg. Further, the substance was found to be non-irritating to the more sensitive eye, providing hence an additional justification for skin irritation data waiving with no risk to underestimate the potential hazard of the substance.

Justification for classification or non-classification

The test item 3-(Cyclohexylamino)-propane sulfonic acid, 3-CAPS showed no effects in a GLP OECD 437 guideline study on the cornea of the bovine eye. This in vitro method allows the identification of corrosive chemical substances and mixtures or of substances which do not require classification. The calculated IVIS (in vitro irritancy score) is -0.01. According to OECD Guideline no. 437 (Jul. 2013), a substance with an IVIS ≤ 3 requires no classification for eye irritation or serious eye damage. The experiment is considered as sufficient for the classification of the test item, because all three replicates of the test item lead to the same assessment for the test item. This single in vitro test can serve as a stand-alone test as it was consistently shown that the test item does not require classification (eye damage).

No pathological changes on the treated skin of male and female rats were found in an acute dermal toxicity test at a dose of 2000 mg/kg, the substance was found to be non-irritating to the more sensitive eye. Hence, classification as irritating to the skin is also not triggered.