Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation / corrosion, other
Remarks:
in vivo study that was performed prior to current requirement for in vitro alternative testing
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
Species:
guinea pig
Strain:
Hartley
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
24 hours
Observation period:
2 weeks
Number of animals:
five (5)
Irritation parameter:
other: Observation
Score:
ca. 0
Max. score:
0
Remarks on result:
other: The was no numerical scoring used, but IUCLID TCC demands a value, so "0" was used as a placeholder.
Irritant / corrosive response data:
Slight or very slight edema was observed in one of 5 and 3 of 5 guinea pigs, respectively, at 24-48 hours after exposure to m-diisopropylbenzene. Edema was accompanied by moderate to severe erythema in 2 of 5 guinea pigs, and well-defined erythema in 2 of 5 guinea pigs. Moderate to severe erythema without edema was observed in one of 5 guinea pigs at 24-48 hours after exposure. For all test animals, there were no signs of edema or erythema at 2 weeks after exposure.
animal no. finding skin (post-exposure)
24-48 hrs 2 weeks
1 erythema mod-severe normal
edema normal
2 erythema well-defined normal
edema very slight normal
3 erythema mod-severe normal
edema very slight normal
4 erythema mod-severe normal
edema slight normal
5 erythema well-defined normal
edema very slight normal
Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: not specified
Conclusions:
The test article, m-diisopropylbenzene, was determined to be slightly irritating
Executive summary:

Slight or very slight edema was observed in one of 5 and 3 of 5 guinea pigs, respectively, at 24-48 hours after exposure to m-diisopropylbenzene. Edema was accompanied by moderate to severe erythema in 2 of 5 guinea pigs, and well-defined erythema in 2 of 5 guinea pigs. Moderate to severe erythema without edema was observed in one of 5 guinea pigs at 24-48 hours after exposure. For all test animals, there were no signs of edema or erythema at 2 weeks after exposure. This compound was determined to be slightly irritating

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation, other
Remarks:
in vivo study that was performed prior to current requirement for in vitro alternative testing
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Justification for type of information:
in vivo study that was performed prior to current requirement for in vitro alternative testing
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 mL of undiluted material was applied to each of 2 eyes of 3 rabbits; material was immediately washed from one eye of each rabbit with distilled water
Duration of treatment / exposure:
one single application
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
3
Irritation parameter:
other: Observation
Score:
ca. 0
Max. score:
0
Remarks on result:
other: The was no numerical scoring used, but IUCLID TCC demands a value, so "0" was used as a placeholder.
Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: not specified
Conclusions:
The test substance, m-diisopropylbenzene, was considered to be a slight eye irritant
Executive summary:

Slight irritation was observed in the conjunctiva and nicitating membrane of 3 of 3 rabbits at one hour after instillation of 0.1 mL of m-diisopropylbenzene. After 24 hours, irritation was not observed in the conjunctiva and nicitating membrane, but was observed in the eyelids in 3 of 3 rabbits. By 48 hours, there were no signs of ocular irritation in any treated animal. There were no signs of irritation observed in the cornea or iris at any time during the study. The test substance was considered to be a slight eye irritant.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for selection of skin irritation / corrosion endpoint:
Slight or very slight edema was observed in one of 5 and 3 of 5 guinea pigs, respectively, at 24-48 hours after exposure to m-diisopropylbenzene. Edema was accompanied by moderate to severe erythema in 2 of 5 guinea pigs, and well-defined erythema in 2 of 5 guinea pigs. Moderate to severe erythema without edema was observed in one of 5 guinea pigs at 24-48 hours after exposure. For all test animals, there were no signs of edema or erythema at 2 weeks after exposure. This compound was determined to be slightly irritating

Justification for selection of eye irritation endpoint:
Slight irritation was observed in the conjunctiva and nicitating membrane of 3 of 3 rabbits at one hour after instillation of 0.1 mL of m-diisopropylbenzene. After 24 hours, irritation was not observed in the conjunctiva and nicitating membrane, but was observed in the eyelids in 3 of 3 rabbits. By 48 hours, there were no signs of ocular irritation in any treated animal. There were no signs of irritation observed in the cornea or iris at any time during the study. The test substance was considered to be a slight eye irritant.

Effects on skin irritation/corrosion: slightly irritating

Effects on eye irritation: slightly irritating

Justification for classification or non-classification

In two independent studies, m-diisopropylbenzene (m-DIPB) produced slight, transient irritation when applied to the skin of guinea pigs, and therefore does not satisfy the criteria for classification as a dermal irritant according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 or UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS). 

When instilled into the eye, m-DIPB produced mild and transient irritation of the conjunctiva, but no evidence of corneal opacity in rabbits.  Based upon these findings, m-DIPB does not satisfy the criteria for classification as an ocular irritant according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 or UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS).