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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:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
8 October 1996 - 21 January 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study conducted in accordance with OECD Guideline.
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
Bodyweight was evaluated on the day of dosing.
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: HRP inc. and Charles River Laboratories, USA
- Age at study initiation: 5-7 weeks
- Weight at study initiation: Male: 391-489 g; female 366 - 480 g
- Housing: Individually housed in suspended, stainless steel cages with wire mesh bottoms
- Diet (e.g. ad libitum): Agway Prolab Purina Guinea Pig Diet; ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: 15 d


ENVIRONMENTAL CONDITIONS
- Temperature and humidity was controlled daily
- Photoperiod (hrs dark / hrs light): 12/12 h
Route:
intradermal and epicutaneous
Vehicle:
propylene glycol
Concentration / amount:
Induction: Intradermal injection 5%, epicutaneous application 100%
Challange: 100%
Route:
epicutaneous, open
Vehicle:
propylene glycol
Concentration / amount:
Induction: Intradermal injection 5%, epicutaneous application 100%
Challange: 100%
No. of animals per dose:
20
Details on study design:


RANGE FINDING TESTS: Yes (Intradermal: October 1st 1996 - October 3rd 1996; Topical: October 1st 1996 - October 4th 1996)
Two animals were pre-treated with two intradermal injections of FCA/water emulsion (1:1) approx. one week prior to test material administration.
Animals were administered 0.1 mL of the test substance (5% w/v) in propylene glycol via injection on either side of the spinal column and observed for dermal irritation 24 h and 48 h after injection.
For the topical range-finding study animals (3 per sex) were dosed with 0.1 mL of four different concentrations (25%, 50%, 75% and 100% in ethyl alcohol) at different sites, two on either side of the column. Treatment was for 24 h under occlusive conditions and observed for dermal irritation 24 h and 48 h afterwards.



MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Test groups: 1
- Control group: 2 (positive and irritation control)
- Site: A row of three injections was made on each side in the shoulder region (Application scheme see Table 1).
- Frequency of applications: Days 1 and 8
- Duration: 25 days
- Concentrations: Intradermal induction: 5%, Topical induction: 100%


B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 14 d after last induction application
- Exposure period: 24 h (Application scheme see Table 1).
- Test groups: 1
- Control group: 2 (positive and irritation control)
- Site: Flank
- Concentrations: 100%
- Evaluation (hr after challenge): 24 and 48 h after removal of the patches






Positive control substance(s):
yes
Remarks:
Hexylcinnamic aldehyde (HCA)
Positive control results:
In the range of the historical controls
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
100%
No. with + reactions:
2
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 100%. No with. + reactions: 2.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
50%
No. with + reactions:
3
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 50%. No with. + reactions: 3.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
100%
No. with + reactions:
1
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 1.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
100%
No. with + reactions:
2
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 100%. No with. + reactions: 2.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
50%
No. with + reactions:
2
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 50%. No with. + reactions: 2.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In a guinea pig maximisation test, read-across substance, 2-ethyl-2-(hydroxymethyl)-1,3-propanediol octanoate, was not classified as a sensitiser.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The results of a guinea pig maximisation test showed that read-across substance, 2-ethyl-2-(hydroxymethyl)-1,3-propanediol octanoate, is not classified as a skin sensitiser. Therefore, by read-across, heptanoic acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3- propanediol pentanoate is not considered to be a skin sensitiser.


Migrated from Short description of key information:
By read-across, heptanoic acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol pentanoate is not considered to be a skin sensitiser.

Justification for selection of skin sensitisation endpoint:
Only 1 study is available.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

Not assessed. No evidence of respiratory sensitisation was noted in any of the studies conducted, and it is proposed that the substance is not a respiratory sensitiser.


Migrated from Short description of key information:
Not assessed. No evidence of respiratory sensitisation was noted in any of the studies conducted, and it is proposed that the substance is not a respiratory sensitiser.

Justification for classification or non-classification

The above study has been ranked reliability 1 according to the Klimisch et al system. This ranking was deemed appropriate because the studies were conducted to GLP an in compliance with agreed protocols. Sufficient dose ranges and numbers are detailed; hence it is appropriate for use based on reliability and animal welfare grounds.

The above results triggered no classification under the Dangerous Substance Directive (67/548/EEC) and the CLP Regulation (EC No 1272/2008).