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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

Constituent 1
Chemical structure
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 levelsopen allclose all
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.
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