Registration Dossier

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:
other: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report Date:
2004

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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
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 (Limit test)
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.
Remarks on result:
other: CL not applicable
Mortality:
No mortalities
Clinical signs:
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.
Body weight:
No effects on body weights were noticed.
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:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
The acute dermal toxicity 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.