Glycerides, C16-18 and C18-unsatd. mono- and di-, citrates

Skin sensitisation

Administrative data

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:

other: Study performed according to internationally accepted testing guideline, well documented, without GLP.

Justification for type of information:

refer to category justification report provided in IUCLID section 13

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Version / remarks:

Maximisation test [Magnusson B. and Kligman A. M. (1969) J. Invest. Dermatol., 52, 268-276.]

Deviations:

no

GLP compliance:

no

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

A non-LLNA which was conducted in 1985 with a current scientifically accepted methodology for assessing skin sensitisation potential is available. Even though the available guinea pig maximisation test (GMPT) is not the preferred method for skin sensitisation testing according to the REACH legislation (EC no 1907/2006) and CLP Regulation (EC No 1272/2008) it is still however an adequate method for skin sensitisation testing. Therefore, a LLNA is not required as adequate data from a GMPT are available (study scientifically not necessary/ other information available).

Test material

Test material information

Constituent 1

Reference substance name:

Glycerides, C16-18 mono-, di- and tri-, hydrogenated, citrates, potassium salts

EC Number:

294-600-1

EC Name:

Glycerides, C16-18 mono-, di- and tri-, hydrogenated, citrates, potassium salts

Cas Number:

91744-38-6

Molecular formula:

not available; UVCB

IUPAC Name:

Glycerides, C16-18 (even numbered) mono-, di- and tri-, hydrogenated, citrates, potassium salts

In vivo test system

Test animals

Species:

guinea pig

Strain:

other: albino

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: David Hall Limited, Burton-on-Trent, Staffordshire, U. K.
- Age: 8 – 12 weeks
- Weight at study initiation: 345 – 438 g
- Housing: housed in groups of up to four in solid floor polypropylene cages furnished with softwood sawdust
- Diet (e.g. ad libitum): guines pig diet, J.Waring Ltd (feeds), Shardlow, Derbyshire
- Water (e.g. ad libitum): The drinking water was supplemented daily with vitamin C tablets
- Acclimation period: not mentioned

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): not mentioned
- Air changes (per hr): 20
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

intradermal and epicutaneous

Vehicle:

other: intradermal: liquid paraffin B.P.; topical: petroleum jelly B.P.

Induction 2

Concentration / amount:

Intradermal Induction: 5%
Topical Induction: 25%
Topical challenge: 25%

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

other: intradermal: liquid paraffin B.P.; topical: petroleum jelly B.P.

Challenge 2

Concentration / amount:

Intradermal Induction: 5%
Topical Induction: 25%
Topical challenge: 25%

No. of animals per dose:

test animals: 10 (main test); 6 (range finding)
control animals: 5

Details on study design:

RANGE FINDING TESTS: Intradermal Injection: An area of 4x6 cm at the shoulder region of 2 animals were clipped. Into these areas were injected simultaneousely four 0.1 ml intradermal injections of the test material with the following concentrations: guinea pig A: 1% and guinea pig B: 5% in paraffin. Animals were observed 24, 48, 72 h and 7 days following treatment. Topical Application: The test material at two concentrations, was topically applied under an occlusive patch to four sites on the shaved flanks of each of a group of two guinea pigs. These animals had previously been intradermally injected with FDA. Following a 24 h exposure period the patches were removed and the degrees of irritancy at the test sites were evaluated for erythema immediately after removal of the patches and then at 24 and 48 h. The concentrations of the test material to be used on two further animals were chosen, applied and then evaluated after similar time intervals.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1
- Exposure period: intradermal: 5% w/v in paraffin;
- Concentration in Freunds Complete Adjuvants (FCA): 5% in in 50% v/v FCA/paraffin
- Test group: dermal: test substance in paraffin
- Control group: paraffin
- Frequency of applications: induction on days 0 and 7
- Duration: removal of patches after 48 hours
- Concentrations: 5% w/v

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: on day 21
- Exposure period: dermal application for 24 hours
- Test groups: test substance in paraffin
- Control group: test substance in paraffin
- Site: flank-region
- Concentrations: 5% w/v
- Evaluation (hr after challenge): 24 and 48 hours after application

Positive control substance(s):

not specified

Results and discussion

In vivo (non-LLNA)

Results

Results 1

Key result

Reading:

1st reading

Hours after challenge:

24

Group:

negative control

Dose level:

Induction: 0%; challenge: 25%

No. with + reactions:

0

Total no. in group:

6

Remarks on result:

other: Reading: 1st reading. Hours after challenge: 24.0. Group: negative control. Dose level: induction: 0%; challenge: 25%. No with. + reactions: 0.0. Total no. in groups: 5.

Results 2

Key result

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

induction: 5%; challenge: 25%

No. with + reactions:

0

Total no. in group:

10

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: induction: 5%; challenge: 25%. No with. + reactions: 0.0. Total no. in groups: 10

Any other information on results incl. tables

RESULTS OF PILOT STUDY: Guinea pig A (concentration 1%): 24, 48 and 72 h slight erythema, 7 days none. Guinea pig B, (concentration 5%): 24, 48, 72h and 7 days slight erythema.

 

RESULTS OF TEST

- Sensitization reaction: No animals of the test or control groups produced reactions at either the test or vehicle control sites, at the 24 or 48 h readings.

- Clinical signs: No clinical signs were reported.

- Grading system: according to the Magnusson and Kligman grading scale for the evaluation of challenge patch test reactions

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified

Executive summary:

The sensitizing potential of the test substance (CAS 91744-38-6, Glycerides, C16-18 mono-, di- and tri-, hydrogenated, citrates, potassium salts) was investigated in a study according to OECD Guideline No. 406 "Skin Sensitization (maximization test)”.

The following numbers of guinea pigs were used in the study: 10 (main test); 6 (range finding), control animals: 5.

The substance concentrations for induction were 5 % (intradermal induction) and 25 % (topical induction). The concentration for topical challenge was 25 %. The vehicle for intradermal induction was liquid paraffin B.P. Petroleum jelly B.P. was used for topical induction and challenge.

Animal sites were graded according to the Magnusson and Kligman grading scale for the evaluation of challenge patch test reactions.

No animals of the test or control groups produced sensitization reactions at either the test or vehicle control sites, at the 24 or 48 h readings. No clinical signs were reported.