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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Justification for type of information:
The study was conducted in the early days of GLP prior to guidelines. The Kodak laboratory used a proprietary in-house method for sensitization called the "footpad method" that was later specifically covered under OECD 406. While documentation is lacking due to the era in which it was conducted, the work was performed at a superior facility and the conclusions are not under question.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
The Kodak Laboratory at this time used a proprietary "footpad" method that was later specifically covered under OECD 406.
GLP compliance:
yes
Type of study:
other: Kodak Footpad Method
Justification for non-LLNA method:
The study was conducted before the existance of the LLNA
Specific details on test material used for the study:
Not provided
Species:
guinea pig
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
Basic Toxicity of Coalescing Solvent EEH/DEH
Route:
other: not provided
Vehicle:
not specified
Route:
other: Not specified
No. of animals per dose:
Not specified
Details on study design:
Not specified
Challenge controls:
Not specified
Positive control substance(s):
not specified
Positive control results:
Not specified
Reading:
1st reading
Hours after challenge:
0
Group:
test chemical
Dose level:
0
No. with + reactions:
0
Total no. in group:
0
Clinical observations:
none
Remarks on result:
other:
Remarks:
placeholder only, ignore
Reading:
1st reading
Hours after challenge:
0
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
0
Clinical observations:
none
Remarks on result:
other:
Remarks:
placeholder only, ignore
Reading:
1st reading
Hours after challenge:
0
Group:
positive control
Dose level:
0
No. with + reactions:
0
Total no. in group:
0
Clinical observations:
none
Remarks on result:
other:
Remarks:
placeholder only, ignore

Sensitization testing was conducted in 1980/1981, at the start of GLP. As a result, the reports are generally under-reported, as standards for report content had not yet been set. The report exists as more of a short summary of the findings, while the primary details of the conduct were kept in generic standard operating proceedures that were applicable to each type of study. As such, individual numeric evaluations were not available for these tests, and the results are reported out in a more general qualatative description. The values for the results provided here are not real and are only placeholders as TCC demanded some sort of entry, even if one was not available.

The laboratory where this work was conducted was the state of the art at the time, and was one of the top labs in the world. We have no reason to doubt the results of the studies, but the findings are not reported out in such way that they are very applicable to entry as a robust summary today.

Interpretation of results:
GHS criteria not met
Conclusions:
The study conclusion was not sensitizing
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Justification for classification or non-classification

The substance was not a skin sensitizer, so no classification was necessary