N-(tert-butyl)benzylamine

Endpoint summary

Description of key information

Corrosive to the skin and severe damage to the eye.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

21 July 1987 to 3 August 1987

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

Guideline study under concurrent standards of quality assurance.

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

GLP compliance:

not specified

Specific details on test material used for the study:

NBTB, batch 7200. Purity 98-101%.

Vehicle:

unchanged (no vehicle)

Control samples:

not required

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

The New Zealand White rabbits were sourced from Buckmasters, Henham, Hertfordshire.
Age: 10-11 weeks.
Weight: 2.3 to 2.4 kg.
Rabbits were individually housed in metal cages with perforated floors
They had free access to tap water and SDS Rabbit Diet
Animal Room temperature was maintained at 19 degrees celcius
12 hours of light and 12 hours of darkness were given.
19 air changes per hour were given.
Humidity at 30-70%

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

14 days

Number of animals:

Three

Irritation parameter:

erythema score

Basis:

mean

Time point:

14 d

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks on result:

probability of severe irritation

Remarks:

severe reaction with necrosis

Irritation parameter:

edema score

Basis:

mean

Time point:

14 d

Score:

1.5

Max. score:

2

Reversibility:

not specified

Remarks on result:

positive indication of irritation

Irritant / corrosive response data:

Severe reactions with necrosis were observed in all 3 animals, which persisted to day 14. One animal was found dead on day 12.

Interpretation of results:

Category 1 (corrosive) based on GHS criteria

Conclusions:

A single semi-occlusive application of N-Benzyl-Tert-Butylamine to intact rabbit skin for four four hours elicited severe dermal irritation with persistent signs including necrosis..

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (corrosive)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study need not be conducted because the available information indicates that the criteria are met for classification as corrosive to the skin or irritating to eyes

Justification for type of information:

According to Annex VII, Section 8.2, Column 2, of Regulation EC No. 1907/2006, the assessment of eye irritation does not need to include a study for eye irritation if criteria are met for classification as corrosive to the skin or irritating to eyes. A valid in vivo dermal irritation study was conducted on this substance, with the conclusion of the substance being corrosive to skin. The substance is considered to cause serious damage to the eye.

Endpoint conclusion

Endpoint conclusion:

no study available

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Studies of the effects on the skin of distilled NBTB showed severe irritation with necrosis, persisting for 14 days. The substance is considered corrosive to the skin. As such, the substance is also considered to cause severe damage to the eye, according to the Guidance on Application of the CLP Criteria, ECHA, 2015, and Annex VII, Section 8.2, Column 2, Regulation EC No. 1907/2006 as amended by Regulation EC No. 863/2016.

Justification for classification or non-classification

Studies of the effects on the skin of distilled NBTB showed severe irritation with necrosis, persisting for 14 days. The substance is considered corrosive to the skin. As such, the substance is also considered to cause severe damage to the eye, according to the Guidance on Application of the CLP Criteria, ECHA, 2015, and Annex VII, Section 8.2, Column 2, Regulation EC No. 1907/2006 as amended by Regulation EC No. 863/2016.