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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
August 2017 - January 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report date:
2018

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
8,9,10-trinorborna-2,5-diene
EC Number:
204-472-0
EC Name:
8,9,10-trinorborna-2,5-diene
Cas Number:
121-46-0
Molecular formula:
C7H8
IUPAC Name:
bicyclo[2.2.1]hepta-2,5-diene
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material: AIR LIQUIDE ELECTRONICS MATERIALS Batch N° 10006042
- Purity: 99.8%
- Expiry date: 16 August 2018

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
- Stability and homogeneity of the test material under test conditions and during storage: stable

In vitro test system

Test system:
human skin model
Source species:
human
Cell type:
non-transformed keratinocytes
Cell source:
foreskin from a single donor
Amount/concentration applied:
16 µL
Duration of treatment / exposure:
42 mins
Duration of post-treatment incubation (if applicable):
42h
Number of replicates:
3

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
Mean
Value:
6.8
Vehicle controls validity:
valid
Positive controls validity:
valid

Any other information on results incl. tables










































































































































 

Skin



OD



Mean OD / disc (#)



Mean OD/ product



Viability



Mean viability



SD viability



Conclusion



Negative control



1



0.772



0.810



0.653



124.0



100.0



20.8


 

0.824



0.834



2



0.555



0.579



88.6



0.595



0.587



3



0.542



0.571



87.4



0.591



0.579



Positive control



4



0.014



0.016



0.012



2.4



1.8



0.6



Irritant



0.018



0.015



5



0.011



0.011



1.7



0.010



0.010



6



0.009



0.009



1.4



0.008



0.008



Test item


PH-17/0495



10



0.034



0.034



0.045



5.2



6.8



5.2



Irritant or Corrosive



0.034



0.032



11



0.018



0.017



2.6



0.016



0.015



12



0.082



0.083



12.7



0.080



0.087


Applicant's summary and conclusion

Interpretation of results:
Category 1 (corrosive) based on GHS criteria
Conclusions:
In accordance with the Regulation EC No. 1272/2008 and in absence of information on skin corrosion, the test item BCHD-Bicyclo 2,2,1-Hepta 2,5 diene has to be classified in Category 2 "Irritating to skin" or in Category 1 "Corrosive". The hazard statement "H315: Causes skin irritation" with the signal word "Warning" or "H314: Causes severe skin burns and eye damage" with the signal word "Danger" are required.
In absence of further information, the precautionary classification as Category 1 "Corrosive" was chosen.
Executive summary:

The aim was to evaluate the possible irritating effects of the test item BCHD-Bicyclo 2,2,1-Hepta 2,5 diene after topical application on in vitro human reconstructed epidermis (SkinEthic RHE@ model).


The test item BCHD-Bicyclo 2,2,1-Hepta 2,5 diene was applied as supplied, at the dose of 16 µL, to 3 living Reconstructed Human epidermis (SkinEthic RHE® model) during 42 minutes. The application was followed by a rinse with 25 mL of DPBS and a 42 hours and 40 minutes postincubation period at 37°C, 5% CO2. Cell viability was then measured by enzymatic conversion of the vital dye MTT into a blue formazan salt that was quantitatively measured after extraction from tissues. The experimental protocol was established in accordance with O.E.C.D. Test Guideline No. 439 adopted 28 July 2015 and the Test method B.46 of Council regulation No. 761/2009 dated 23 July 2009 (EU Journal L220) - ATP Council regulation No. 440/2008 of 30 May 2008 (E.U. Journal L142).


The mean percent viability of the treated tissues was 6.8%, versus 1.8% in the positive control (5% Sodium Dodecyl Sulfate).


In accordance with the Regulation EC No. 1272/2008 and in absence of information on skin corrosion, the test item BCHD-Bicyclo 2,2,1-Hepta 2,5 diene has to be classified in Category 2 "Irritating to skin" or in Category 1 "Corrosive". The hazard statement "H315: Causes skin irritation" with the signal word "Warning" or "H314: Causes severe skin burns and eye damage" with the signal word "Danger" are required