Registration Dossier
Registration Dossier
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EC number: 206-058-5 | CAS number: 298-12-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1984
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was performed according to OECD Guideline No. 404 "Acute Dermal Irritation/Corrosion"
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- Institut Français de Toxicologie, Les Oncins, BP 109 - 69210 L´Abresie, France
Test material
- Reference substance name:
- Glyoxylic acid
- EC Number:
- 206-058-5
- EC Name:
- Glyoxylic acid
- Cas Number:
- 298-12-4
- Molecular formula:
- C2H2O3
- IUPAC Name:
- 2-oxoacetic acid
- Details on test material:
- Glyoxylic Acid 50 %
pH-value: 0.3 (at T= 21 °C)
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
Six male Albino New Zealand rabbits (per test), weighing about 2.5 kg (+/- 200 g) at the beginning of the study, originating from
accredited breeders.
- Housing:
The rabbits are kept in individual polystyrene cages, measuring 500 x 560 x 360 mm with a perforated polystyrene floor in a ventilated
and air conditioned room.
- Diet: 150 g of complete maintenance food (granulés Lapin Entretien "112" UAR, 91360 - Villemoisson/ Orge) is provided per rabbit and
per day.
- Water: provided ad libitum
- Acclimation period:
Before the start of the experiment, the animals are kept for at least 8 days to allow time for acclimatization. They were vaccinated against
the principal respiratory (pasteurellosis) and digestive diseases of the rabbit (Lysopast and Oventero; Institut Mérieux) and myxomatosis
(lyomyxovax; Institut Mérieux). These animals are selected at random, after elimination of animals showing possible cutaneous lesions.
One ear of each animal is pierced and a metal tag (Chevillot: La Quick) is attached for individual identification.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 °C +/- 3 (throughout the year)
- Humidity (%): 30 - 70 %
- Air changes (per hr): 12 - 14 times per hour (pre filtered air: 5-10 µ)
- Photoperiod (hrs dark / hrs light): 12 hrs artificial light at each 24 hour period
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped back and flanks of rabbits
- Vehicle:
- other: product used pure
- Controls:
- no
- Amount / concentration applied:
- Application of the test substance:
0.5 ml of the test substance as such, applied with a sterile polypropylene syringe (Bectan Dickinson) of 2 ml, on a Codex hydrophilic eight layer gauze pad, about 2.5 cm square, previously laid down on the skin to avoid any loss of test substance.
Method of application:
The test substance and the gauze pad are held in contact with the skin with a semi-occlusive patch: 10 cm wide adhesive perforated tape (Paloplast: M.S.R) applied on a crimped gauze bandage (Creplux - Molinier) covering more particularly the whole clipped surface (to avoid possible orthoergic reactions) and wrapped around the animal (without blocking the respiratory and abdominal movements). - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 6
- Details on study design:
- The test substance is kept in contact with the skin for 4 hours, the animals are retained in plastic restraining boxes (Iffa Crédo).
After these 4 hours of exposure, the bandagings are removed, and when necessary the excess of the test substance which has not penetrated is wiped with a gauze pad moistened with deionized water (or a non-irritant solvent). The animals are then returned to their individual cages.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: 022
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal: 023
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal: 024
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal: 025
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal: 026
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal: 027
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- edema score
- Basis:
- animal: 022
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal: 023
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal: 024
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal: 025
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal: 026
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal: 027
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- not irritating
- Executive summary:
In a primary dermal irritation study conducted according to OECD TG 404, six male Albino New Zealand rabbits (per test), weighing about 2.5 kg (+/- 200g) at the beginning of the study were dermally exposed to 0.5 ml of Glyoxalic Acid 50% for 4 hours to a body surface area of 2.5 cm square. Animals then were observed for 3 days. Cutaneous Primary Irritation was scored according to the AFNOR protocol (NF T03 -263). Only one animal (No. 027) showed a slight erythema (barely perceptile) and no other skin irritating effect was observed by all the animals during the whole study period. Based on these results it can be concluded that Glyoxylic Acid 50% is not irritating to the rabbits skin.
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