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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
Study period:
1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well documented, according to accepted guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The study was performed before the implementation of the REACH regulkation.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Hexylene Glycol
- Physical state: liquid
- Analytical purity: 99.75%
- Lot/batch No.: 9609P0518
- Storage condition of test material: room temperature and protected from light

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Centre d'Elevage Lebeau, 78950 Gambais, France
- Age at study initiation: approximately 3 months old
- Weight at study initiation: mean body weight ± standard deviation of 336 ± 21 g for males and 317 ± 13 g for females
- Housing: individually in polycarbonate cages
- Diet (e.g. ad libitum): 106 pelleted diet available ad libitum
- Water (e.g. ad libitum): filtered by a F.g. Millipore membrane and provided ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2
- Humidity (%): 30 to 70
- Air changes (per hr): 12 cycles/hr
- Photoperiod (hrs dark / hrs light): 12/12


Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
physiological saline
Concentration / amount:
0.1 ml of 10% (w/w) of test substance in vehicle for intradermal injections and 0.5 mL of the test substance in original form for cutaneous route
Challengeopen allclose all
Route:
intradermal
Vehicle:
physiological saline
Concentration / amount:
0.1 ml of 10% (w/w) of test substance in vehicle for intradermal injections and 0.5 mL of the test substance in original form for cutaneous route
No. of animals per dose:
5 animals/sex for control and 10 animals/sex for treated group
Details on study design:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 6
- Site: anterior, middle, posterior in the dorsal region between the shoulders
- Concentrations: 10% (w/w) in vehicle


B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 1
- Exposure period: 24 hrs
- Site: posterior right flank
- Concentrations: 0.5 ml of test substance in original form
- Evaluation (hr after challenge): 24 and 48 hr

Positive control substance(s):
yes
Remarks:
2,4-Dinitrochlorobenzene (DNCB)

Study design: in vivo (LLNA)

Statistics:
Irritation graded according to scale

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0.5 mL of the test substance in original form
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0.5 mL of the test substance in original form. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0.5 mL of the test substance in original form
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0.5 mL of the test substance in original form. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
0.5 mL of the test substance in original form
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.5 mL of the test substance in original form. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
0.5 mL of the test substance in original form
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.5 mL of the test substance in original form. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.

Any other information on results incl. tables

See attached Table for results

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
According to the maximization method of Magnusson and Kligman, no cutaneous reactions attributable to the sensitization potential of Hexylene Glycol were observed in guinea-pigs.
Executive summary:

The skin sensitization potential of hexylene glycol was assessed in a study performed according to OECD Guidelines for the Testing of Chemicals No. 406 and in compliance with GLP in male and female Dunkin Hartley guinea pigs (de Jouffrey, 1997). In the main study, 10 animals comprised the hexylene glycol test group and 5 animals comprised the vehicle control group. The intracutaneous induction was carried out with 0.1 ml of 10% (w/w) of hexylene glycol in vehicle (physiological saline), and dermal induction was performed with 0.5 mL of undiluted hexylene glycol to the dorsal area under occlusive conditions. The challenge exposure also was conducted with 0.5 mL of undiluted hexylene glycol. Additionally, all animals were dermally exposed to 0.5 mL of 10% w/w sodium lauryl sulphate (SDS) in vaseline 24 hours prior to topical sensitization of the skin area in order to induce local irritation (hexylene glycol was shown to be non-irritating in the preliminary test). Skin reactions were observed and recorded 1 hour after dermal induction and 24 and 48 hours after the challenge exposure, all according to the grading scale by Magnusson and Kligman. Test and control animals displayed normal body weight gain throughout the investigation and no mortalities were observed. Clinical signs included hypoactivity and piloerection in one male of the treated group on Days 13 and 14, which are consisted with the clinical signs observed in other studies on hexylene glycol. On Day 10, following dermal induction, signs of irritation were observed at the site of application in both control and treated groups. Following the challenge exposure, no incidences of erythema or oedema were observed, either at 24 or 48 hours, in all animals. Under the experimental conditions and according to the maximization method of Magnusson and Kligman, no cutaneous reactions attributable to the sensitization potential of hexylene glycol were observed in guinea-pigs. Therefore, the results of this study demonstrated that hexylene glycol showed no evidence of contact skin sensitization in guinea pigs