Glutaral

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1975

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The study was conducted prior to the implementation of the actual guidelines and GLP was not compulsory at the time the study was performed. However, the study was based on an acknowledged standardized test method and was conducted according to an acceptable BASF test; basic data were given.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Principles of method if other than guideline:

BASF test:
The aim of the present test was to look for the sensitizing potential of glutaraldehyde using the open epicutaneous test with guinea pig, which is an acknowledged standardized test method.
For induction, the unchanged test substance was applied to the shaved left flank (area 25 cm2) of 10 Pirbright White Guinea pigs. Application was performed once daily, for 5 consecutive days, over 2 weeks (total of 10 applications). The shaved right flank remained untreated.
Following an 11-day recovery period, both flanks were shaved once again and the unchanged test substance was applied, this time to the right flank of each treated animal (single application). Three control animals, which had not been previously subjected to induction, were treated similarly. Skin reactions were recorded after 12 hours.

GLP compliance:

no

Remarks:

; GLP was not compulsory at the time the study was performed.

Type of study:

open epicutaneous test

Justification for non-LLNA method:

The study was performed in 1975, before the LLNA OECD TG 429 was in place (adopted in 2002).

Test material

Test material information

Constituent 1

Reference substance name:

Glutaral

EC Number:

203-856-5

EC Name:

Glutaral

Cas Number:

111-30-8

Molecular formula:

C5H8O2

IUPAC Name:

glutaraldehyde

Test material form:

liquid

Specific details on test material used for the study:

- Name of test material (as cited in study report): Glutaraldehyde 25% aq. solution
- Physical state: liquid
- Analytical purity: 25.0% glutaraldehyde

In vivo test system

Test animals

Species:

guinea pig

Strain:

other: Pirbright White guinea pigs

Sex:

female

Study design: in vivo (non-LLNA)

Induction

Route:

epicutaneous, open

Vehicle:

unchanged (no vehicle)

Concentration / amount:

The application area was a skin area of 25 cm2

Challenge

Route:

epicutaneous, open

Vehicle:

unchanged (no vehicle)

Concentration / amount:

The application area was a skin area of 25 cm2

No. of animals per dose:

Treated females: 10
Control females: 3

Details on study design:

INDUCTION EXPOSURE
- No. of exposures: 10 applications
- Exposure period: 2 weeks
- Test groups: one group comprising 10 animals
- Site: left flank, clipped 25 cm2 area within the fore region; the shaved right flank remained untreated

CHALLENGE EXPOSURE
- No. of exposures: single application
- Day(s) of challenge: challenge was conducted after a recovery period of 11-day following induction
- Exposure period: 12 hours
- Test groups: one induced group comprising 10 animals
- Control group: Three control animals, which had not been previously subjected to induction, were challenged.
- Site: both flanks were shaved again and the unchanged test substance was applied, this time to the right flank of each treated animal
- Evaluation (hr after challenge): after 12 hours following challenge

Results and discussion

In vivo (non-LLNA)

Results

Results 1

Reading:

1st reading

Hours after challenge:

12

Group:

test chemical

Dose level:

single application of glutaraldehyde 25% on a skin area of 25 cm2

No. with + reactions:

10

Total no. in group:

10

Clinical observations:

All animals showed slight spot-like redness of the skin and brownish residues of the test substance.

Remarks on result:

positive indication of skin sensitisation

Results 2

Reading:

1st reading

Hours after challenge:

12

Group:

negative control

Dose level:

single application of glutaraldehyde 25% on a skin area of 25 cm2

No. with + reactions:

0

Total no. in group:

3

Clinical observations:

None of the control animal showed skin reaction. Brownish test substance residues on the skin were seen.

Remarks on result:

no indication of skin sensitisation

Any other information on results incl. tables

Repeated induction treatment with the undiluted test substance caused necrotic skin lesions with thick bloody
crusts in all animals. Upon challenge treatment of the opposite flank with the undiluted test substance performed
after an 11-day period without treatment, all animals exhibited slight erythema. No signs of irritation were seen
in the three untreated controls.

Applicant's summary and conclusion

Conclusions:

Glutaraldehyde 25% was sensitizing to guinea pig when tested in the open epicutaneous test.