Reaction mass of glycerol, glycerol 1-formate, glycerol 2-formate, glycerol 1,2-diformate, glycerol 1,3-diformate and glycerol triformate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

1

Reference substance name:

Reaction mass of glycerol, glycerol 1-formate, glycerol 2-formate, glycerol 1,2-diformate, glycerol 1,3-diformate and glycerol triformate

EC Number:

701-316-8

Molecular formula:

C5H8O5 & C4H8O4

IUPAC Name:

Reaction mass of glycerol, glycerol 1-formate, glycerol 2-formate, glycerol 1,2-diformate, glycerol 1,3-diformate and glycerol triformate

Specific details on test material used for the study:

Reported as: Glycerol formates

Test animals

Species:

rat

Strain:

Wistar

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Envigo RMS (UK) Limited
- Females nulliparous and non-pregnant: Yes
- Age at study initiation: 8 to 12 weeks
- Weight at study initiation: 200 g
- Housing: Suspended solid floor polypropylene cages furnished with woodflakes. The animals were housed individually during the 24-Hour exposure period and in groups of five, by sex, for the remainder of the study
- Diet: ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature: 19 to 25 °C
- Humidity: 30 to 70%
- Air changes: at least fifteen changes per hour
- Photoperiod: 12 hours continuous light and 12 hours darkness

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

Amount applied: 2000 mg/kg bw (1.57 mL/kg)

Duration of treatment / exposure:

24-hour contact period

Observation period:

The animals were observed for deaths or overt signs of toxicity 30 minutes, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days

Number of animals:

5/sex/dose

Details on study design:

TEST SITE
- Area of exposure: back and flanks
- % coverage: 10% of the total body surface area
- Type of wrap if used: surgical gauze was placed over the treatment area and semi-occluded with a piece of self-adhesive bandage
REMOVAL OF TEST SUBSTANCE
- Washing: After the 24-Hour contact period the bandage was carefully removed and the treated skin and surrounding hair wiped with cotton wool moistened with distilled water

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: All 10 animals

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

animal: All 10 animals

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

There were no signs of dermal irritation

Executive summary:

Dermal irritation was assessed during an acute dermal toxicity study. Ten rats (5/sex/dose) were exposed to 2000 mg/kg bw of test substance with semi-occlusive dressing for a total contact time of 24 hours. No erythema or edema was observed in any of the ten animals during the 24/48/72 hour time period or during any point during the 14 day observation period.

 

The test substance is not a skin irritant.