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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation / corrosion
Remarks:
in vitro
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Experimental Data: 19 Jan 2016 (Preliminary Data Collected 06 Jan 2016)
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study completed according to OECD 435 Guidelines, and under GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous

In vitro test system

Test system:
other: Bovine Cornea
Source species:
other: Cow
Cell type:
other: Cornea
Cell source:
other:

Test animals

Species:
other: N/A - Macromolecular Barrier

Test system

Type of coverage:
other: In vitro
Duration of treatment / exposure:
Single Exposure

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
penetration time (in minutes)
Value:
> 70.25
Vehicle controls validity:
valid
Negative controls validity:
valid
Remarks:
Citric acid
Positive controls validity:
valid
Remarks:
1.0 N Sodium hydroxide
Remarks on result:
no indication of irritation
Remarks:
Non Corrosive

Any other information on results incl. tables

The positive control, 1.0 N Sodium Hydroxide, was categorized as received and the negative control, Citric Acid, was used as a 10% solution in water. The results of both controls were considered valid.

Applicant's summary and conclusion

Interpretation of results:
other: Non-corrosive
Remarks:
Criteria used for interpretation of results: OECD GHS
Conclusions:
The material was considered non-corrosive.
Executive summary:

Benzene, mono-C10 -13 -alkyl derivatives, distillation residues, sulfonated, sodium salts was determined to be compatible with the Corrositex system. Then, a formulation of 10% test material in water 100 uL test material : 900 uL tissue culture water) was categorized by pH to determine Category 2 cut-off times should be used to determine corrosivity. 0.5 mL of the test article was added to each of four Corrositex® test vials containing biobarriers and the times required for the test article to permeate or destroy the biobarriers were recorded. A positive control (1.0 N sodium hydroxide) and a negative control (1% citric acid) were tested concurrently. The average breakthrough time for the four test material samples was >70.25 minutes. The test material was considered non-corrosive.