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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report date:
1977

Materials and methods

Principles of method if other than guideline:
10 male albino guinea pigs were exposed to 25% and 2.5% of test substance in propylene glycol on the shaved intact shoulder skin. Irratation was observed after 24 and 48 h. To test for sensitisation, a series of sacral intradermal injections was given with 0.1 ml of 1% test substance in dimethyl phthalate. Following a 2 week rest period, the animals were chaleenged by rubbing 1 drop (ca 0.05 ml) of 25% and a 2.5% solution of the test substance on the intact shaven shoulder skin. A group of 10 previously unexposed guinea pigs of similar age received similar applications.
GLP compliance:
no
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Reference substance name:
Cyclohexane, oxidized, non-volatile residue
EC Number:
270-147-5
EC Name:
Cyclohexane, oxidized, non-volatile residue
Cas Number:
68411-76-7
Molecular formula:
contains many components
IUPAC Name:
5-hydroxypentanoic acid; 6-hydroxyhexanoic acid; hexanedioic acid; oxolan-2-one; pentanoic acid
Constituent 2
Reference substance name:
Cyclohexane oxidized, non-volatile residue
IUPAC Name:
Cyclohexane oxidized, non-volatile residue

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: albino
Sex:
male

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
propylene glycol
Concentration / amount:
25 and 2.5%. Intradermal injections were done with 1% test substance in dimethyl terephthalate
Challengeopen allclose all
Route:
epicutaneous, open
Vehicle:
propylene glycol
Concentration / amount:
25 and 2.5%. Intradermal injections were done with 1% test substance in dimethyl terephthalate
No. of animals per dose:
10
Challenge controls:
10
Positive control substance(s):
no

Results and discussion

Any other information on results incl. tables

The test substance solution of 25% was slightly irritating to the skin of 7 of the 10 animals after 24 h. Therefore the challenge results could only be observed with the 2.5% solution. No effects were observed in all 10 animals.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Executive summary:

not sensitizing for skin