Reaction mass of (1R,4S,4aR,8R,8aS)-9-(dichloromethylidene)-8-hydroxyoctahydro-1,4-methanonaphthalen-5(1H)-one and (1S,4R,4aS,8S,8aR)-9-(dichloromethylidene)-8-hydroxyoctahydro-1,4-methanonaphthalen-5(1H)-one and (1R,4S,4aR,8S,8aS)-9-(dichloromethylidene)-8-hydroxyoctahydro-1,4-methanonaphthalen-5(1H)-one and (1S,4R,4aS,8R,8aR)-9-(dichloromethylidene)-8-hydroxyoctahydro-1,4-methanonaphthalen-5(1H)-one

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

2010-12-15 - 2010-12-16 (experimental phase)

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

This study provides some useful information about the properties of the test item. However it has been conducted only at a screening level. No specific reference to a guideline is given in the study report. However it is assumed that the study design has been based on the main principles of a corresponding relevant guideline and that the study did not follow the corresponding guideline in detail. The level of information collected/reported is limited. In addition the study has not been performed according to GLP. As a consequence the reliability ("evaluating the inherent quality of a test report or publication relating to preferably standardized methodology and the way the experimental procedure and results are described to give evidence of the clarity and plausibility of the findings"), relevance ("covering the extent to which data and tests are appropriate for a particular hazard identification or risk characterization") and adequacy ("defining the usefulness of data for hazard/risk assessment purposes") of the data ("data quality") are considered as limited and an overall reliability rating of 3 (= not reliable, according to the scoring system of Klimisch et al.) has been assigned.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

The skin corrosivity potential of the test item was assessed using the Transcutaneous Electrical Resistance (TER) Assay, according to a general study plan of the test facility. This involved the application of the test item to the epidermal surface of skin discs, obtained from a humanely killed young Wistar strain rat.

GLP compliance:

no

Remarks:

However, the study was conducted in a facility operating to Good Laboratory Practice within the UK national GLP monitoring programme. The analytical characterisation of the test material has been performed according to GLP.

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of (1R,4S,4aR,8R,8aS)-9-(dichloromethylidene)-8-hydroxyoctahydro-1,4-methanonaphthalen-5(1H)-one and (1S,4R,4aS,8S,8aR)-9-(dichloromethylidene)-8-hydroxyoctahydro-1,4-methanonaphthalen-5(1H)-one and (1R,4S,4aR,8S,8aS)-9-(dichloromethylidene)-8-hydroxyoctahydro-1,4-methanonaphthalen-5(1H)-one and (1S,4R,4aS,8R,8aR)-9-(dichloromethylidene)-8-hydroxyoctahydro-1,4-methanonaphthalen-5(1H)-one

EC Number:

700-770-4

Molecular formula:

C12H14Cl2O2

IUPAC Name:

Reaction mass of (1R,4S,4aR,8R,8aS)-9-(dichloromethylidene)-8-hydroxyoctahydro-1,4-methanonaphthalen-5(1H)-one and (1S,4R,4aS,8S,8aR)-9-(dichloromethylidene)-8-hydroxyoctahydro-1,4-methanonaphthalen-5(1H)-one and (1R,4S,4aR,8S,8aS)-9-(dichloromethylidene)-8-hydroxyoctahydro-1,4-methanonaphthalen-5(1H)-one and (1S,4R,4aS,8R,8aR)-9-(dichloromethylidene)-8-hydroxyoctahydro-1,4-methanonaphthalen-5(1H)-one

Test animals

Species:

other: not applicable (in vitro test using skin discs, obtained from a humanely killed young Wistar strain rat)

Strain:

other: not applicable (in vitro test using skin discs, obtained from a humanely killed young Wistar strain rat)

Test system

Type of coverage:

other: not applicable

Preparation of test site:

other: not applicable

Vehicle:

unchanged (no vehicle)

Controls:

other: not applicable

Amount / concentration applied:

no data

Duration of treatment / exposure:

24 h

Observation period:

not applicable

Number of animals:

not applicable

Details on study design:

The prepared pelt from the rat was used for skin disc preparation. The integrity of each pelt was confirmed using a Quality Control test. Only acceptable pelts were used to supply skin discs for use in the main study.
The test item was applied to the epidermal surface of three skin discs for a contact period of 24 hours. At the end of the contact period the test item was removed using a jet of warm tap water. Corrosive items produce an irreversible loss of normal stratum corneum integrity and function, this is measured as a reduction in the inherent TER. A threshold value has been established (5kΩ) below which, items are considered likely to be corrosive in vivo. The TER was measured using a low voltage alternating current electronic databridge.

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

transcutaneous electrical resistance (in kΩ)

Value:

23.7

Vehicle controls validity:

not examined

Negative controls validity:

valid

Positive controls validity:

valid

Any other information on results incl. tables

Table: Results

Treatment	Mean electrical resistance (standard deviation)
Test item	23.7 kΩ (± 6.2)
Negative Control item	12.4 kΩ (± 2.3)
Positive Control Item	0.900 kΩ (± 0.023)

Applicant's summary and conclusion

Interpretation of results:

other: see Conclusions below

Conclusions:

This study provides some useful information about the properties of the test item. However it has been conducted only at a screening level. No specific reference to a guideline is given in the study report. However it is assumed that the study design has been based on the main principles of a corresponding relevant guideline and that the study did not follow the corresponding guideline in detail. The level of information collected/reported is limited. In addition the study has not been performed according to GLP.

As a consequence the reliability ("evaluating the inherent quality of a test report or publication relating to preferably standardized methodology and the way the experimental procedure and results are described to give evidence of the clarity and plausibility of the findings"), relevance ("covering the extent to which data and tests are appropriate for a particular hazard identification or risk characterization") and adequacy ("defining the usefulness of data for hazard/risk assessment purposes") of the data ("data quality") are considered as limited and an overall reliability rating of 3 (= not reliable, according to the scoring system of Klimisch et al.) has been assigned.

Executive summary:

A screening level in vitro study for skin corrosivity (Transcutaneous Electrical Resistance (TER) Assay) has been conducted. Following assessment of the data the test item was considered unlikely to have the potential to cause corrosion in vivo.