Registration Dossier

Administrative data

Description of key information

Justification for selection of skin irritation / corrosion endpoint:
Only one study available.

Justification for selection of eye irritation endpoint:
Only one study available.

Effects on skin irritation/corrosion:slightly irritating

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation / corrosion, other
Remarks:
The study is in vivo as the study already available based on literature already published.
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1975=1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Due to absence of information on number of animal reliability category according to Klimisch is 3 (red score). Evaluator proposal is 2 (“reliable with restrictions”) because number of animals in compliance with method can be various.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no
Remarks:
The study was conducted in 1975 whereas OECD and EU Guidelines as well as GLP Principles were implemented in 1981 and 1988
Species:
rabbit
Strain:
other: New Zealand
Type of coverage:
other: intact and abraded skin
Preparation of test site:
shaved
Vehicle:
other: 50% paste with peanut oil prepared just prior to application
Controls:
other: 67% suspension of lactose in peanut oil was used
Amount / concentration applied:
50% paste with peanut oil
Duration of treatment / exposure:
24 and 72h
Observation period:
24 and 72h
Number of animals:
6 rabbbits with intact and abraded skin in each test groups
Remarks on result:
probability of mild irritation
Other effects:
A red pigment appeared on the skin after the TNT was applied (red color under all patches at 24h). Mild irritant.

Slightly irritating.

Interpretation of results:
GHS criteria not met
Conclusions:
Not irritating according to Regulation (EC) no 1272/2008 (CLP).
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation, other
Remarks:
The study is in vivo as the study already available based on literature already published.
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1975-1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Due to absence of information on number of animal reliability category according to Klimisch is 3 (red score). Evaluator proposal is 2 (“reliable with restrictions”) because number of animals in compliance with method can be various.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no
Remarks:
The study was conducted in 1975 whereas OECD and EU Guidelines as well as GLP Principles were implemented in 1981 and 1988
Species:
rabbit
Strain:
other: New Zealand
Vehicle:
other: 50% paste with peanut oil prepared just prior to application
Controls:
other: 67% suspension of lactose in peanut oil was used
Amount / concentration applied:
50% paste with peanut oil
Duration of treatment / exposure:
24 and 72h.
Observation period (in vivo):
24 and 72h.
Number of animals or in vitro replicates:
6 rabbits per test groups.
Remarks on result:
no indication of irritation
Other effects:
Red pigment appeared around the eye after TNT was applied (red color around the eye at 24h). TNT did not produce eye irritation.

Not irritating.

Interpretation of results:
not irritating
Conclusions:
Not irritating according to Regulation (EC) no 1272/2008 (CLP).
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

The substance does not meet the criteria for classification as skin or eye irritant.