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Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1986-03-17 to 1986-04-01
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP study according to OECD-TG.
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0,5 ml
Duration of treatment / exposure:
4hrs
Observation period:
30-60min, 24h, 48h, 72h
Number of animals:
3
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24h, 48h, 72h
Score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24h, 48h, 72h
Score:
0
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study according to OECD TG 404 nitro-m-xylene was not irritating to the 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:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Study period:
1986-03-17 to 1986-04-1
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well performed study according to GLP and previous OECD TG.
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
12 May 1981
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye served as contorl
Duration of treatment / exposure:
24 hrs
Observation period (in vivo):
1h, 24h, 48h and 72h after administration
Number of animals or in vitro replicates:
3
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24h, 48h, 72h
Score:
0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24h, 48h, 72h
Score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24h, 48h, 72h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24h, 48h, 72h
Score:
0
Other effects:
1hr after application clear eye discharge was observed in all animals.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study according to OECD TG 405 nitro-m-xylene was not irritating to the eye.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Justification for classification or non-classification

No datas are available for 2 -nitro-p-xylene. But according to the studies cited and according to "Toxikological evaluation No. 94 2 -Nitro-1,4 -dimethylbenzene" from Berufsgenossenschaft der chemischen Industrie, Vol. 04/94, ISSN-0937.4248, the isomeric nitroxylenes are not irritating to eye or skin. In analogy it can be predicted, that the target substance will not be an irritant.