Reaction mass of 3-(octanoyloxy)propyl decanoate and propane-1,3-diyl didecanoate and propane-1,3-diyl dioctanoate

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

02.12.1991 - 03.01.1992

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Version / remarks:

February 1987

GLP compliance:

yes (incl. QA statement)

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

The Guinea Pig Test (1992) met the previous requirements before the entry into force of REACH. The test is suitable and reliable to cover this endpoint. For this reason and for animal welfare reasons, no further in vivo study (LLNA test) needs to be performed.

Test material

Test material information

Constituent 1

Reference substance name:

C8-10-1,3-Butandiolester

Molecular formula:

Not available, UVCB

IUPAC Name:

C8-10-1,3-Butandiolester

In vivo test system

Test animals

Species:

guinea pig

Strain:

Dunkin-Hartley

Remarks:

Pirbright White Bor: DHPW [SPF]

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Winkelmann, D-W-4799 Borchen
- Age at study initiation: young
- Weight at study initiation: 362 - 467 g
- Housing: Maximum 5 animals/type IV Makrolon cage
- Diet: Ssniff G 4 complete feed for guinea pigs, supplied by Ssniff Spezialfutter GmbH, D-W-4770 Soest
- Water: Drinking water ad libitum, supplied by Gelsenwasser, waterworks, D-W-4358 Haltern
- Acclimation period: at least 5 days
- Indication of any skin lesions: no

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C
- Humidity (%): 30-70% (deviations due to cleaning of the animal room and function checks on the thermohygrograph)
- Photoperiod: Artificial light, 12-hour light/dark rhythm

- IN-LIFE DATES: From: To: 02.12.1991 - 03.01.1992

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

intradermal

Vehicle:

corn oil

Concentration / amount:

10 %

Induction 2

Route:

epicutaneous, occlusive

Vehicle:

unchanged (no vehicle)

Concentration / amount:

0.3 cm³

Day(s)/duration:

48 h

Challenge

No.:

#1

Route:

epicutaneous, occlusive

Vehicle:

unchanged (no vehicle)

Concentration / amount:

100 %

Day(s)/duration:

24 and 48 h

No. of animals per dose:

20 animals per dose

Details on study design:

RANGE FINDING TEST:
All the test substance concentrations (0.25; 0.5; 1.0; 2.5; 5 and 10% in maize germ oil MEH 56) and the pure vehicle caused very slight erythema and well-defined oedema at the injection sites in both animals 24 hours after the intracutaneous administration. On the basis of these results, a 10% formulation of the substance in maize germ oil MEH 56 was chosen for the intracutaneous induction in the main test. None of the test substance concentrations administered (2.5; 25; 50 and 100%) caused dermal reactions 48 and 72 hours after administration so that the 100% test substance was used for the dermal administration in the main test.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Test groups: 20 animals
- Control group: 10 animals
- Site: on the shoulder
- Frequency of applications: once
- Concentrations: 10 %

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Days of challenge: 7
- Exposure period: 24 h
- Test groups: 20 animals
- Control group: 10 animals
- Site: right flank
- Concentrations: 100%
- Evaluation (hr after challenge): 48 and 72 h

Positive control substance(s):

no

Results and discussion

In vivo (non-LLNA)

Results

Results 1

Key result

Reading:

1st reading

Hours after challenge:

48

Group:

test chemical

Dose level:

100 %

No. with + reactions:

0

Total no. in group:

20

Results 2

Reading:

1st reading

Hours after challenge:

48

Group:

negative control

Dose level:

0 %

No. with + reactions:

0

Total no. in group:

10

Results 3

Reading:

2nd reading

Group:

test chemical

Remarks on result:

not measured/tested

Results 4

Group:

positive control

Remarks on result:

not measured/tested

Any other information on results incl. tables

The reactions to the dermal induction treatment were assessed 49 and 72 hours after administration. Distinct redness and swelling was found at the injection sites treated with 10% test substance in maize germ oil MEH 56 49 hours after administration. Scaling was detected at the injection sites after 24 hours. Severe erythema and severe oedema occurred 49 hours after administration in 19/20 test animals at the injection sites treated with 10% test substance in Freund's Adjuvant (diluted 1+1 with maize germ oil MEH 56). One animal had well-defined reddening and swelling. Nine animals were found to have deep damage. 24 hours later (72 hours after administration) 19 animals were found to have severe erythema with deep damage and severe oedema. One animal had moderately severe redness and swelling. The control animals had comparable signs of irritation at the injection sites at these times. The first challenge treatment was carried out with the 100% test substance. There were no signs of skin irritation in the administration area 24 and 48 hours after removal of the occlusive dressing (48 h and 72 h after administration) either in the test animals or in the animals in control group. No second challenge was carried out because the above result was unambiguous.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In a Magnusson and Kligman maximisation test groups of guinea pigs showed no sensitizing effects.

Executive summary:

The sensitising potential of the test item was determined using a test group of 20 animals and two control groups each of 10 animals for the test. All the reactions, especially the formation of erythema and oedema, were assessed 48 and 72 hours after the challenge treatment. The following concentrations of test substance were used for the induction treatments: the test substance was employed in a 10% mixture with maize germ oil MEH 56 for the intracutaneous injection, while the 100% test substance was used for the dermal treatment. The preliminary tests showed that the undiluted test substance caused no dermal irritation. In order to induce slight to moderate dermal inflammation, 24 hours before the dermal induction treatment the skin in the injection area was pretreated with sodium dodecyl sulphate (10% in vaseline). The reactions to the dermal induction treatment were assessed 49 and 72 hours after administration. Distinct redness and swelling was found at the injection sites treated with 10% test substance in maize germ oil MEH 56 49 hours after administration. Scaling was detected at the injection sites after 24 hours. Severe erythema and severe oedema occurred 49 hours after administration in 19/20 test animals at the injection sites treated with 10% test substance in Freund's Adjuvant (diluted 1+1 with maize germ oil MEH 56). One animal had well-defined reddening and swelling. Nine animals were found to have deep damage. 24 hours later (72 hours after administration) 19 animals were found to have severe erythema with deep damage and severe oedema. One animal had moderately severe redness and swelling. The control animals had comparable signs of irritation at the injection sites at these times. The first challenge treatment was carried out with the 100% test substance. No signs of dermal irritation were found on the test animals or the control animals 48 hours and 72 hours after the challenge treatment. No second challenge was carried out. On the basis of these results, the test item is assessed as having no sensitising effect on the skin of guinea pigs.