Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
2002

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Annex V
GLP compliance:
yes
Type of study:
Freund's complete adjuvant test
Justification for non-LLNA method:
No justification given

Test material

Constituent 1
Reference substance name:
-
EC Number:
444-000-2
EC Name:
-
Cas Number:
Not specified
Molecular formula:
Not applicable because it is a UVCB substance.
IUPAC Name:
3-[3-(pentanoyloxy)-2,2-bis[(pentanoyloxy)methyl]propoxy]-2,2-bis[(pentanoyloxy)methyl]propyl pentanoate; 3-{3-[(3,5,5-trimethylhexanoyl)oxy]-2,2-bis({[(3,5,5-trimethylhexanoyl)oxy]methyl})propoxy}-2,2-bis({[(3,5,5-trimethylhexanoyl)oxy]methyl})propyl 3,5,5-trimethylhexanoate

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
not specified

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
other: not specified
Vehicle:
other: Freund's Complete Adjuvant
Concentration / amount:
not specified
Day(s)/duration:
not specified
Adequacy of induction:
not specified
Route:
other: not specified
Vehicle:
arachis oil
Concentration / amount:
25% w/v test material in arachis oil
Day(s)/duration:
not specified
Adequacy of induction:
not specified
Route:
other: not specified
Vehicle:
other: Freund's Complete Adjuvant
Concentration / amount:
25% w/v test material in Freund's Complete Adjuvant
Day(s)/duration:
not specified
Adequacy of induction:
not specified
Route:
other: Topical Induction
Vehicle:
unchanged (no vehicle)
Concentration / amount:
undiluted test material
Day(s)/duration:
not specified
Adequacy of induction:
not specified
Challengeopen allclose all
Route:
other: Topical Challenge
Vehicle:
other: undiluted and arachis oil
Concentration / amount:
undiluted and 75% v/v in arachis oil BP
Day(s)/duration:
not specified
Adequacy of challenge:
not specified
Route:
intradermal
Vehicle:
arachis oil
Concentration / amount:
25% w/v in arachis oilBP
Day(s)/duration:
not specified
Adequacy of challenge:
not specified
No. of animals per dose:
Number of animals in test group: 10
Number of animals in negative control group: 5
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
75%
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
75%
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
75%
No. with + reactions:
0
Total no. in group:
5
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
5
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
75%
No. with + reactions:
0
Total no. in group:
5
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
5
Group:
positive control
Remarks on result:
not measured/tested

Any other information on results incl. tables

Maximum concentration not causing irritating effects in preliminary test: 100%

Signs of irritation during induction:

Skin reactions observed after intradermal induction presented as very slight to well defined erythema of all test animals at 24 and 48 -hour observation. Very slight erythema as noted at the intradermal induction sites of all control group animals at the 24 -hour observation an in two control animals at the 48 -hour observation.Skin reactions observed after topical induction presented as very slight or well-defined erythema and an isolated incident of very slight oedemawere noted at the induction sites of five test group animals at 24 -hour observation.Bleeding from the intradermal induction sites was noted in three test group animals at the 1 -hour observation. Residual test material was noted at the induction site of three test group animals at the 1 -hour observation. No evidence of skin irritation was noted at the treatment sites of control group animals at the 24 -hour observation.

Evidence of sensitisation of each challenge concentration: The test material produced a 0% (0/10) sensitisation rate.

Other observations:

None

Applicant's summary and conclusion

Interpretation of results:
other: not classified