Amines, C12-14-tert-alkyl, compds. with 2(3H)-benzothiazolethione

Endpoint summary

Description of key information

Skin irritation

Key study

The study has been performed to the standardised guideline OECD 435. However, no statement of GLP has been made. The results of this study indicated that the sample was compatible with the Corrositex system and was classified as a Category 2 material. The results obtained from the evaluation of four replicate samples were highly reproducible, demonstrating that a mean time of >60 minutes required to destroy the synthetic biobarriers. These findings lead to the designation of the test material as a UN Non-corrosive and not a GHS Category 1 (InVitro International, 2016).

Eye irritation

Key study (in vivo)

In a study conducted according to the U.S. Federal Hazardous Substances Act, the test material when applied undiluted to the eyes of albino rabbits produced corneal opacity, conjunctivitis, iritis, and conjunctival bleeding. The test material is classified as a Category 1 according to GHS (Hill Top Research, Inc., 1971).

 

Waiver (in vitro)

An in vitro eye irritation does not need to be conducted because adequate data from an in vivo eye irritation are available; the study is scientifically not necessary as other information is available.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

3 February 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)

Deviations:

no

GLP compliance:

not specified

Specific details on test material used for the study:

Not specified.

Test system:

artificial membrane barrier model

Source species:

other: Artificial barrier

Cell type:

other:

Cell source:

other: Not specified

Source strain:

other: Not applicable

Vehicle:

unchanged (no vehicle)

Details on test system:

A qualification test was performed to insure the test sample and the test reagent are compatible.

The second step of the Corrositex test utilizes appropriate indicator solutions to permit categorization of the test sample as either a Corrositex Category 1 or Corrositex Category 2 material. Corrositex Category 1 materials are typically strong acids/bases, while Corrositex Category 2 materials are typically weak acids/bases.

The third step in the test is performed by applying the test sample to the biobarrier. When the chemical permeates through or destroys the full thickness of this biobarrier, it comes into contact with the reagent which then undergoes a simple color change. This color change is visually observed and the time required for the color change to occur is recorded.

Control samples:

no

Amount/concentration applied:

150 µL

Duration of treatment / exposure:

0 to 3 minutes, >3 to 60 minutes, >60 to 240 minutes, and >240 minutes.

Duration of post-treatment incubation (if applicable):

Not applicable

Number of replicates:

4

Irritation / corrosion parameter:

penetration time (in minutes)

Run / experiment:

1, 2, 3, and 4

Value:

> 60

Vehicle controls validity:

not applicable

Negative controls validity:

not applicable

Positive controls validity:

not applicable

Remarks on result:

other: Not corrosive

Summary of Corrositex^®Test Results

Replicate	Corrositex Time (minutes)
1	>60
2	>60
3	>60
4	>60
Mean	>60

 

Additional Test Information:

- Concentration of test material tested: Neat

- pH(10%) : 8.45

- Corrositex Category: 2

- UN Packing Group: Non-corrosive

- GHS Skin Corrosion Category: Not Category 1

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

Under the conditions of the study, the test material has been determined not to be corrosive.

Executive summary:

The study has been performed to the standardised guideline OECD 435. However, no statement of GLP has been made. The results of this study indicated that the sample was compatible with the Corrositex system and was classified as a Category 2 material. The results obtained from the evaluation of four replicate samples were highly reproducible, demonstrating that a mean time of >60 minutes required to destroy the synthetic biobarriers. These findings lead to the designation of the test material as a UN Non-corrosive and not a GHS Category 1.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (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:

02 June 1971 to 09 September 1971

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

according to guideline

Guideline:

other: U.S. Federal Hazardous Substances Act

Version / remarks:

September 17, 1964

Deviations:

no

GLP compliance:

no

Specific details on test material used for the study:

- Description: Viscous, amber liquid with an unpleasant odor

Species:

rabbit

Strain:

not specified

Remarks:

Albino

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

1 μL

Observation period (in vivo):

24, 48 and 72 hours following application

Details on study design:

J. H. Draize, “Dermal Toxicity,” in Appraisal od the Safety of Chemicals in Foods, Drugs and Cosmetics, The Staff of the Division of Pharmacology of the Federal and Drug Administration (Austin, Texas: The Editorial Committee of the Association of Food and Drug Officials of the United States, 1959), p. 51.

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24/48/72 h

Score:

> 16 - < 83

Max. score:

110

Reversibility:

not fully reversible within: 72 hrs

Remarks on result:

positive indication of irritation

Irritative effects included moderate or marked corneal opacity and conjunctivitis and mild iritis in each animal. Onset of these irritative effects was within 24 hours following application and they were relatively unchanged in five animals throughout the study. Irritative effects subsided significantly in the sixth animal. Four animals exhibited bleeding of the conjunctivae at the 24- and/or 48-hour observations.

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Conclusions:

Application of the test material to the eyes of albino rabbits produced corneal opacity, conjunctivitis, iritis, and conjunctival bleeding.

Executive summary:

In a study conducted according to the U.S. Federal Hazardous Substances Act, the test material when applied undiluted to the eyes of albino rabbits produced corneal opacity, conjunctivitis, iritis, and conjunctival bleeding. The test material is classified as a Category 1 according to GHS.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irreversible damage)