Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Skin irritation:

The dermal irritation potential of target chemical was assessed in in-vivo experimental study.Based on the available studies,it can be concluded that the test chemical is unable to cause skin irritation and considered as not irritating. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified''.

Eye irritation:

The ocular irritation potential of target chemical was assessedin various in- vitro and in-vivo experimental studies.Based on the available studies,it can be concluded that the test chemical is unable to cause eye irritation and considered as irritating. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Category 2".

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
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Data is from peer reviewed journal
Qualifier:
according to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
Skin irritation study was conducted to test the effects of m chloronitrobenzene on new Zealand rabbits after 24 hr.
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
No data available
Type of coverage:
other: semi-occlusive bandage with adhesive plaster
Preparation of test site:
not specified
Vehicle:
other: 0.3 ml propylene glycol
Controls:
not specified
Amount / concentration applied:
No data available
Duration of treatment / exposure:
30 and 60 minutes
Observation period:
24hr
Number of animals:
3 animals
Details on study design:
No data available
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24hrs
Remarks on result:
other: Non irritating, Hardly noticeable erythema
Irritant / corrosive response data:
No data available
Other effects:
No data available
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
m-Chloronitrobenzene was found to be non- irritating to skin.
Executive summary:

m-Chloronitrobenzene was applied as a paste made with 0.3 ml propylene glycol, and covered with a semi-occlusive bandage which was affixed to the application site with ad-hesive plaster. Following the exposure period, the chemical was removed from the skin with lukewarm water. Assessments of the treated area of skin after 30 and 60 minutes revealed mild, hardly noticeable erythema in 2 animals. After 24 hours, the animals no longer showed any signs of irritation. Therefore, m-chloronitrobenzene was not irritating to the rabbit skin .

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Data is from review article or handbook
Qualifier:
according to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
Eye irritation study was conducted to test the effects of m chloronitrobenzene on new Zealand rabbits.
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
No data available
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
100 mg dose of the 99% pure chemical
Duration of treatment / exposure:
72hrs
Observation period (in vivo):
72hrs and after 7 days for an reversible effect
Number of animals or in vitro replicates:
3 animals
Details on study design:
TEST SITE
- Area of exposure: conjunctival sac of the left eye
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72
Remarks on result:
other: Slightly irritating, Hyperaemia of the conjunctival blood vessels,slight cloudiness of the cornea
Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
At 1 and 24hr mild to moderate swelling and severe reddening of the conjunctivae occurred. At 48 hours after treatment, one animal showed marked hyperaemia of the conjunctival blood vessels Two animals exhibited slight cloudiness of the cornea. At 72 hours after treatment, 2 animals were still observed to have marked Hyperaemia of the conjunctival blood vessels After 7 days, all signs of irritation were reversible. Therefore, m-chloronitrobenzene was evaluated as slightly irritating to the eye.
Executive summary:

The effects of m-chloronitrobenzene on the eye were studied in 3 New Zealand rabbits which had a single 100 mg dose of the chemical (99% pure) instilled into the conjunctival sac of the left eye. Twenty-four hours prior to the beginning of the experiment, and 72 hours after administration, one drop of sodium fluorescein solution was instilled into the treated eye of each animal, and damage to the cornea was assessed under ultraviolet light. Inspection of the treated eyes at 1, 24, 48 and 72 hours after instillation gave the following results. At 1 and 24 hours after treatment, mild to moderate swelling and severe reddening of the conjunctivae occurred. Two animals exhibited slight cloudiness of the cornea. At 48 hours after treatment, one animal showed marked hyperaemia of the conjunctival blood vessels. The iris of that animal was reddened, while the cornea was slightly clouded. At 72 hours after treatment, 2 animals were still observed to have marked hyperaemia of the conjunctival blood vessels. After 7 days, all signs of irritation were reversible. Therefore, m-chloronitrobenzene was evaluated as slightly irritating to the eye.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation:

In different studies, the test chemical has been investigated for potential for dermal irritation to a greater or lesser extent. The studies are based on in- vitro and in-vivo experiment conducted in human and rabbits which have been summarized as below:

m-Chloronitrobenzene was applied as a paste made with 0.3 ml propylene glycol, and covered with a semi-occlusive bandage which was affixed to the application site with ad-hesive plaster. Following the exposure period, the chemical was removed from the skin with lukewarm water. Assessments of the treated area of skin after 30 and 60 minutes revealed mild, hardly noticeable erythema in 2 animals. After 24 hours, the animals no longer showed any signs of irritation. Therefore, m-chloronitrobenzene was not irritating to the rabbit skin .

The dermal irritation potential of test article was determined according to the OECD 439 test guideline for this study. The MatTek EpiDerm™ model was used to assess the potential dermal irritation of the test article by determining the viability of the tissues following exposure to the test article via MTT. Tissues were exposed to the test article and controls for ~one hour, followed by a 42 hour post-exposure recovery period. The viability of each tissue was determined by MTT assay.The MTT data show the assay quality controls were met and passed the acceptance of criteria.The mean of OD for test chemical was determined to be 2.304. The standard deviation of viabilities for test chemical were calculated to be 6.39.The Mean % tissue viability compared to negative control (n=3) of the test chemical was determined to be 99.2%. Hence, under the current experimental test conditions it was concluded that test chemical was considered to be not irritating to human skin.

All these studies lead to a conclusion that Test chemical is indeed not irritating to skin. Hence, comparing the above annotations with the criteria of CLP regulation, Test chemical can be classified under the category “Not Classified”.

Eye irritation:

In different studies, the test chemical has been investigated for potential for ocular irritation to a greater or lesser extent. The studies are based on in- vitro and in-vivo experiment conducted in rabbits conducted which have been summarized as below:

The effects of m-chloronitrobenzene on the eye were studied in 3 New Zealand rabbits which had a single 100 mg dose of the chemical (99% pure) instilled into the conjunctival sac of the left eye. Twenty-four hours prior to the beginning of the experiment, and 72 hours after administration, one drop of sodium fluorescein solution was instilled into the treated eye of each animal, and damage to the cornea was assessed under ultraviolet light. Inspection of the treated eyes at 1, 24, 48 and 72 hours after instillation gave the following results. At 1 and 24 hours after treatment, mild to moderate swelling and severe reddening of the conjunctivae occurred. Two animals exhibited slight cloudiness of the cornea. At 48 hours after treatment, one animal showed marked hyperaemia of the conjunctival blood vessels. The iris of that animal was reddened, while the cornea was slightly clouded. At 72 hours after treatment, 2 animals were still observed to have marked hyperaemia of the conjunctival blood vessels. After 7 days, all signs of irritation were reversible. Therefore, m-chloronitrobenzene was evaluated as slightly irritating to the eye.

The ocular irritation potential of test article was determined according to the OECD 492 test guideline for this study. The MatTek EpiOcular™ model was used to assess the potential ocular irritation of the test articles by determining the viability of the tissues following exposure to the test article via MTT. Tissues were exposed to liquid test articles and controls for ~30 minutes, followed by a ~12 minute post-soak and approximately 2 hour recovery after the post-soak. The viability of each tissue was determined by MTT assay.

The MTT data show the assay quality controls were met, passing the acceptance criteria.

The mean of OD for test chemical was determined to be 0.049.The mean % tissue viability of test chemical was determined to be 2.6%. Hence, under the experimental test conditions it was concluded that test chemical was considered to be irritating to the human eyes.

All these studies lead to a conclusion that Test chemical is indeed not irritating to eye. Hence, comparing the above annotations with the criteria of CLP regulation, Test chemical can be classified under the category “category 2 - irritant”.

Justification for classification or non-classification

The skin and eye irritation potential of test chemical was observed in various studies. The results obtained from these studies indicate that the chemical is not likely to cause skin and is likely to cause eye irritation. Hence the test chemical can be classified under the category “Not Classified” for skin and “category 2 - irritant” for eye as per CLP.

Categories Display