glyoxal … %; ethandial … %

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Remarks:

The test method was comparable to the limit test as described by OECD guideline 402 (1987) without GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

((limit test, 1987)

GLP compliance:

no

Remarks:

the study was carried out in a GLP certified laboratory. However, the study was not monitored by the QAU; therefore, the study was not fully compliant to GLP requirements.

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Glyoxal

EC Number:

203-474-9

EC Name:

Glyoxal

Cas Number:

107-22-2

Molecular formula:

C2H2O2

IUPAC Name:

oxalaldehyde

Test material form:

liquid

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Tank B 401

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Stability under test conditions: Glyoxal as 40% aqueous solution is stable for 6 months

OTHER
- Impurities (identity and concentrations): ethylene glycol, glycol aldehyde, formaldehyde, formic acid, glycolic acid, glyoxylic acid)
- Composition of test material, percentage of components: Glyoxal 40%, ethylene glycol 0.6%, glycol aldehyde 0.15%, formaldehyde 0.015%, formic acid, glycolic acid, glyoxylic acid, 0.1%)

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. K. Thomae GmbH, D-7950 Biberach, Germany
- Weight at study initiation:
mean body weight of the males: 269 g
mean body weight of the females: 227 g
- Fasting period before study: no
- Housing: single housing in steel wire mesh cages, type OK-III (Becker & co. Castrop-Rauxel, Germany)
- Diet (e.g. ad libitum): Kliba-Labordiaet, FA. Klingentalmuehle AG, CH-4303 Kaiseraugst, Switzerland, ad libitum
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Air changes (per hr): housing in fully air-conditioned rooms
- Photoperiod (hrs dark / hrs light): 12 h/ 12 h

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

water

Details on dermal exposure:

Each animal received a single application of unchanged test substance on the clipped skin within the dorsal to dorsolateral region of the trunk; clipping of the fur had been done at least 15 hours prior to treatment. The application volume was 1.57 mL/kg bw and the tested dose level was 2000 mg/kg bw. The application site was covered with a semiocclusive dressing for 24 hours; thereafter, dressing was removed and the application site was rinsed with warm water.

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

10 animals/sex/group were used

Control animals:

no

Details on study design:

- The treatment was followed by a 14-day post -exposure period of observation;
- The animals were observed for mortality twice each workday and once daily at weekends or public holidays;
- They were examined for clinical symptoms of toxicity several times during the application day and at least once daily thereafter;
- Skin findings were scored 30 to 60 minutes following removal of the dressing, and at least once weekly during the observation period;
- The rats were weighed prior treatment and thereafter, on day 2, 7 and 13 post-treatment;
- At the end of the observation period, the surviving animals were sacrificed for the purpose of necropsy;
- Animals that died during the observations period also were subjected to necropsy.

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Neither mortality nor symptoms of toxicity were seen at the tested dose level of 2000 mg/kg bw.

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 800 mg/kg bw

Based on:

act. ingr.

Remarks on result:

other: Neither mortality nor symptoms of toxicity were seen at the tested dose level of 2000 mg/kg bw of test material Glyoxal 40%, i.e., 800 mg/kg bw of the active ingredient.

Mortality:

No mortalities were observed.

Clinical signs:

other: No clinical symptoms of toxicity were observed.

Gross pathology:

All animals survived and were sacrificed at the end of the observation period; necropsy revealed no abnormalities.

Other findings:

Skin examination revealed erythema in both males and females on day 1 following treatment.

Any other information on results incl. tables

Body weight data:

Time point of body weight recording	Males (mean body weight, N = 5)	Females (mean body weight, N = 5)
Initial	269 g	227 g
Day 2	253 g	218 g
Day 7	278 g	230 g
Day 13	347 g	240 g

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met