Reaction products of ethylene glycol, urea and paraformaldehyde (EUF)

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

June 28, 2004 to July 21, 2004 (experimental phase)

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

reaction products of ethylene glycol, urea and paraformaldehyde

EC Number:

700-934-5

Molecular formula:

No exact molecular formula can be given for a complex reaction mixture (UVCB substance).

IUPAC Name:

reaction products of ethylene glycol, urea and paraformaldehyde

Details on test material:

- Name of test material (as cited in study report): Formaldehyddepot EFU (TPI 1618)
- Substance type: Formaldehyde releaser
- Physical state: Clear colourless liquid
- Lot/batch No.: LJ 526/37
- Expiration date of the lot/batch: January 2005
- Other: pH 6-8 at 10g/L (20°C)

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: DIMED Schönwalde
- Weight at study initiation: 210 – 261 g
- Fasting period before study: Overnight prior to dosing
- Housing: Macrolon Type III cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +-3
- Humidity (%): 55 +- 15
- Air changes (per hr): 10
- Photoperiod 12 hrs dark /12 hrs light

IN-LIFE DATES: From June 22, 204 to July 21, 2004

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 6x8 cm
- Type of wrap if used: 4-layer gauze packs fixed with Micropore tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 hours post dosing

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Concentration (if solution): used undilutedly

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 males/5 females

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations 1, 3 and 6 hours after the start of dosing and daily thereafter over 14 days; body weights recorded on days 0, 7 and 14
- Necropsy of survivors performed: yes

Statistics:

No preterminal deaths; therefore no statistical procedures empoyed

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortalities

Clinical signs:

other: Males and females showed piloerection 1, 3 and 6 hours p.a. as well as on day 1. The skin and adjacent areas were yellowish discoloured caused by the test item.

Gross pathology:

External examination of animals at termination of the study did not reveal any lesions of pathological significance.

Any other information on results incl. tables

Table for acute dermal toxicity: clinical signs and pathology
Dose (mg/kg bw.)	Number of dead / number of investigated	Time of death (range)	Observations
2000 mg/kg	males 0/5, females 0/5	n.a.	Clinical signs: Piloerection up to and including Day 1 p.a. in all animals Pathology no specific findings
LD50value	>2000 mg/kg bw.

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute dermal toxicity of Formaldehyddepot EFU (TPI 1618) is low with an LD50 greater than 2000 mg/kg bw.

Executive summary:

The study was performed according to OECD guideline 402 and designed as a limit-test using a single dose of 2000 mg/kg bw in rats. No pre-terminal deaths were observed in any of the rats after dermal application of 2000 mg/kg bw. Clinical signs were limited to piloerection up to and including Day 1 of dosing. Yellowish staining of the skin was induced by the test item.
The LD₅₀for male and female rats after dermal exposure was greater than 2000 mg/kg bw. Thus no classification is required.