Benzenemethanamine, 2-chloro-N,N-dimethyl-

Endpoint summary

Description of key information

Skin irritation/corrosion:

A study was performed for the assessment of the skin corrosion of the test item with reconstructed human epidermis (RhE). The experiment was carried out using the commercially available test method EPISKIN-SM. The study was conducted in accordance with OECD TG 431.Following exposure with the test substance after 4 hours, the mean cell viability was 67% compared to the negative control value. Therefore, the test item was considered as being non-corrosive. The experiment met the validity criteria, therefore the study was considered to be valid.

A dermal irritation/corrosion test according to OECD TG 404 was conducted with test article. The test article (0.5 ml) was applied to the shaved skin of three male rabbits for four hours under occlusive conditions. The test sites were examined for skin irritation at 1, 24, 48, and 72 hours after patch removal. Very slight oedema (score 1) was observed in all animals at the 1 -hour examination. All skin reactions were fully reversed within 72 hours after patch removal. There was no mortality, and there were no remarkable clinical observations. Body weights were not affected by treatment.

Eye irritation:

An eye irritation/corrosion test was conducted with test article according to OECD TG 405. The test article (0.1 ml) was instilled into the conjunctival sac of one eye of three rabbits; the second eye served as a control. The test eyes were gently washed with distilled water 24 hours after treatment. Eyes were examined for irritation at 1, 24, 48 and 72 hours after treatment. Redness of the conjunctiva was observed in all animals at the 1-hour reading. All eye reactions were clear by day 1 after treatment. There was no mortality, and no remarkable clinical observations. Body weights were not affected by treatment.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

May 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))

Qualifier:

according to guideline

Guideline:

OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)

GLP compliance:

yes (incl. QA statement)

Test system:

human skin model

Source species:

human

Cell type:

non-transformed keratinocytes

Justification for test system used:

commercially available test system

Vehicle:

unchanged (no vehicle)

Details on test system:

RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EPISKIN-SM (Manufacturer: SkinEthic, France
- Tissue batch number(s):Batch No.:13-EKIN-016, Expiry Date: 06 May 2013)

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

TEST MATERIAL
- Amount(s) applied: 50 μl
- Concentration (if solution): undiluted
NEGATIVE CONTROL
- Amount(s) applied: 50 μl
- Concentration (if solution): 0.9% NaCl in water
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 50 μl

Duration of treatment / exposure:

The plates with the treated epidermis units were incubated for 4 hours (±10 min) at room temperature (23.4-25.8°C) covered with the plate lids.

Number of replicates:

Two replicates per test item per time point were used. Two negative controls and two positive controls were also run in the assay.

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

exposure period: 4 hours

Value:

67

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Other effects / acceptance of results:

- OTHER EFFECTS:
- Visible damage on test system: No
- Direct-MTT reduction: the test substance did not interact with MTT and therefore using of additional controls was not necessary.
- Colour potential: The colour of the mixture was colourless and therefore using of additional controls was not necessary.

DEMONSTRATION OF TECHNICAL PROFICIENCY:

ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control:
- Acceptance criteria met for positive control:
- Acceptance criteria met for variability between replicate measurements:
- Range of historical values if different from the ones specified in the test guideline:

Interpretation of results:

GHS criteria not met

Executive summary:

A study was performed for the assessment of the skin corrosion of the test item with reconstructed human epidermis (RhE). The experiment was carried out using the commercially available test method EPISKIN-SM. The study was conducted in accordance with OECD TG 431.Following exposure with the test substance after 4 hours, the mean cell viability was 67% compared to the negative control value. Therefore, the test item was considered as being non-corrosive. The experiment met the validity criteria, therefore the study was considered to be valid.

Reference 2

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

May 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

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: S&K-Lap Kft. 2173 Kartal, Császár út 135, Hungary
- Age at study initiation: ca. 12 weeks
- Weight at study initiation: no information available
- Housing: metal cages; individual
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: no information available

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +- 3
- Humidity (%): 40 - 75
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 mL

Duration of treatment / exposure:

4h - The dressing was removed and the skin was flushed with lukewarm tap water to clean the application site.

Observation period:

72h

Number of animals:

3 (males)

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

At observation one hour after patch removal, very slight oedema (score 1) was observed in all animals.

At observation 24, 48 and 72 hours after patch removal, there were no observed clinical signs noted on the skin of the treated animals.

As no clinical signs and no skin irritation effects were observed at 72 hours after patch removal, the study was terminated after the 72 hours observation.

No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred. The body weights of all rabbits were considered to be within the normal range of variability.

Interpretation of results:

GHS criteria not met

Executive summary:

A dermal irritation/corrosion test according to OECD TG 404 was conducted with test article. The test article (0.5 ml) was applied to the shaved skin of three male rabbits for four hours under occlusive conditions. The test sites were examined for skin irritation at 1, 24, 48, and 72 hours after patch removal. Very slight oedema (score 1) was observed in all animals at the 1 -hour examination. All skin reactions were fully reversed within 72 hours after patch removal. There was no mortality, and there were no remarkable clinical observations. Body weights were not affected by treatment.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on the study results for skin and eye irritation no classification according to Regulation (EC) No. 1272/2008 (CLP), ANNEX I, is warranted.