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Description of key information

There was no indication of a local reaction to the skin neither of a systemic effect in an in vivo skin irritation conduced according to OECD TG 404. Additional in vitro assays do also not indicate corrosion/irritation potential.
Dihchlororthanilsäure was evaluated for a potential ocular irritation in an in vitro assay. In this assay cell viability in the human corneal epithelial cell (HCE) construct is measured. This model is recognized as the model of choice and scientifically relevant as documented by several publications. Dichlororthanilsäure was not characterised by a significant impact on cell viability after test item exposure. Thus, Dichlororthanilsaure is identified as non-irritant under the conditions of this in vitro assay.

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:
2012
Reliability:
1 (reliable without restriction)
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
other: Test item was mixed to a paste with sterile water
Controls:
not required
Duration of treatment / exposure:
4 hours
Observation period:
Approximately 1, 24, 48 and 72 hours after the end of the 4 hour exposure period.
Number of animals:
3
Irritation parameter:
other: edema or oedema
Basis:
other: individual animal 1, 2 or 3
Time point:
other: all time points
Score:
0
Max. score:
4
Reversibility:
other: no effect observed
Remarks on result:
other: There was no indication of a local reaction to the skin neither of a systemic effect.
Other effects:
No erythema or oedema was recorded during the observation period.
Interpretation of results:
not irritating
Executive summary:

There was no indication of a local reaction to the skin neither of a systemic effect. These results indicate that the test item, Dichlororthanilsäure, has no irritant effect on the skin of the rabbit following a 4 hour dermal exposure period.

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

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2011
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The HCE is produced and commercialized since 2000 - more than 11 years -, and is the only model made from human corneal cells. The model is routinely used by the major Cosmetic and Pharmaceutical companies, and has already been prevalidated in 2004. Furthermore, this model is recognized as the model of choice and scientifically relevant as documented by several publications.
Qualifier:
no guideline available
Principles of method if other than guideline:
The experiment was carried out on reconstituted human ocular epithelia (SkinEthic™ Human Corneal Epithelial Model (HCE)); The model used for this study is a corneal epithelial tissue (mucosa) without a stratum corneum. The ultra-structure (tissue morphology and thickness) is similar to the corneal mucosa of the human eye
GLP compliance:
yes (incl. QA statement)
Species:
other: in vitro
Strain:
other: in vitro; reconstituted human ocular epithelia
Vehicle:
other: moistened with PBS
Controls:
other: negative and positive controls included
Duration of treatment / exposure:
Human Corneal Epithelial (HCE) inserts were exposed to 30 mg of the test item for 60 min (RT; three inserts per period of incubation time).
Observation period (in vivo):
After the exposure period of 60 minutes the inserts were washed carefully with PBS. After a post-exposure incubation of 16h in the incubator MTT reduction assay was performed.
Duration of post- treatment incubation (in vitro):
60 min.
Number of animals or in vitro replicates:
In vitro; three inserts per period of incubation time.
Irritation parameter:
other: Cell viability in %
Run / experiment:
Decision criteria: ocular irritant if cell viability
Value:
77.3
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Interpretation of results:
GHS criteria not met
Conclusions:
No indication for an eye irritant potential was seen in an in vitro test.
Executive summary:

Dichlororthanilsaure was not characterised by a significant impact on cell viability after test item exposure.

Thus, Dichlororthanilsaure is identified as non-irritant under the conditions of this in vitro assay.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for selection of skin irritation / corrosion endpoint:
Guideline in vivo study

Justification for selection of eye irritation endpoint:
Reliable in vitro method

Justification for classification or non-classification

There was no indication of a local reaction to the skin neither of a systemic effect in an in vivo skin irritation study conduced according to OECD TG 404.

Dihchlororthanilsäure was evaluated for a potential ocular irritation in an in vitro assay (HCE) and is identified as non-irritant under the conditions of this in vitro assay.