Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
22 August 1989 - 5 September 1989
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP study in compliance with international guidelines but the purity of the substance and the certificate of analysis were not reported.
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
No certificate of analysis, no data about purity of the test substance
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
yes
Remarks:
No certificate of analysis, no data about purity of the test substance
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): ER 195
- Physical state: white crystalline powder
- Analytical purity: no data
- Lot/batch No.: DG 6
- Storage condition of test material: room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Bantin & Kingman Ltd., Grimston, U.K.
- Age at study initiation: approximately ten to fourteen weeks old
- Weight at study initiation: males: 201-216 g / females: 201-221 g
- Fasting period before study: no
- Housing: in groups of five by sex in solid-floor polypropylene cages with sawdust bedding
- Diet (e.g. ad libitum): Rat and Mouse Expanded Diet No. 1 (Special Diet Services Limited, Witham, U.K.), ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 54-64
- Air changes (per hr): approximately 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark

IN-LIFE DATES: From: 22 August 1989 To: 5 September 1989

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
arachis oil
Details on dermal exposure:
TEST SITE
- Area of exposure: 10% of the total body area
- Type of wrap if used: 7 cm x 4 cm surgical gauze semi-occluded by a piece of self-adhesive bandage (HYPERTIE) and wrapped with BLENDERM

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with cotton wool moistened with arachis oil
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Concentration (if solution): not applicable
- Constant volume or concentration used: no

VEHICLE
- Amount(s) applied (volume or weight with unit): no data (moistened skin)
Duration of exposure:
24 h
Doses:
2000 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
All animals were observed for overt signs of toxicity and death 1 and 4 h after dosing and subsequently at least once daily for 14 days.
Individual bodyweights were recorded on the day of treatment (day 0) and on days 7 and 14.
All animals were subjected to a gross necropsy examination for any macroscopic abnormalities. No tissues were retained.
Statistics:
None

Results and discussion

Preliminary study:
No data
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No deaths in males and females
Clinical signs:
Signs of toxicity related to dose levels: hunched posture, lethargy and pilo-erection during the first day.
Adverse dermal reactions noted were oedema, blanching and hard, light brown coloured scabs at the site of application with loss of the upper layers of skin and fur resulting in purple/pink areas.
Body weight:
One male showed a small loss in bodyweight over the first week, all other animals showed expected gain in bodyweight over the study period.
Gross pathology:
No abnormalities were noted at necropsy of animals killed at the end of the study.
Other findings:
No data

Any other information on results incl. tables

No data

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the test conditions, ER 195 should not be classified according to the criteria of the Annex VI of the Directive 67/548/EEC and the CLP Regulation (EC) N° (1272-2008).
Executive summary:

ER 195 was tested for acute dermal toxicity in Sprague-Dawley rats in a limit dose assay according to OECD guideline 402 in compliance with GLP. Groups of rats (5/sex) were administered a single dermal dose of ER 195 at 2000 mg/kg bw on clipped skin moistened with arachis oil using a semi-occlusive patch held in place for 24 h. Skin was washed with a cotton wool moistened with arachis oil at the end of the 24-hour exposure period. Examinations for mortality, clinical signs and body weight gain were performed during a 14-day observation period. All surviving animals were necropsied at the end of the observation period. No deaths and clinical signs occurred during the observation period. Body weight gain was not affected by treatment (except for one male). At necropsy, macroscopic examination of main organs showed no abnormalities. The acute dermal combined LD50 was greater than 2000 mg/kg bw.

Adverse dermal reactions noted were oedema, blanching and hard, light brown coloured scabs at the site of application with loss of the upper layers of skin and fur resulting in purple/pink areas.

Under the test conditions, ER 195 should not be classified according to the criteria of the Annex VI of the Directive 67/548/EEC and the CLP Regulation (EC) N° (1272-2008).