Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2001-08-22 - 2001-10-05
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-Guideline Study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
1-(3-sulphonatopropyl)pyridinium
EC Number:
239-491-3
EC Name:
1-(3-sulphonatopropyl)pyridinium
Cas Number:
15471-17-7
Molecular formula:
C8H11NO3S
IUPAC Name:
1-(3-sulfopropyl)pyridin-1-ium
Details on test material:
- Name of test material (as cited in study report): PPS SOLID
- Substance type: organic salt
- Physical state: white solid
- Lot/batch No.: 0300007/131
- Storage condition of test material: room temperature in the dark

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS: Sprague-Dawley CD (Crl: CD® (SD) IGS BR) strain rats
- On receipt the animals were randomly allocated to cages. The females were nulliparous and non-pregnant.
- Source: Charles River (UK) Ltd, Margate, Kent, UK.
- Animal selection: at random and given a unique number within the study by indelible ink-marking on the tail and a number written on a cage card.
- Age at study initiation: approximately eight weeks
- Weight at study initiation: at least 200 g
- Housing: housed in suspended polypropylene cages furnished with wood flakes, individually during the 24-hour exposure period and in groups of five, by sex, for the remainder of the study
- Diet (e.g. ad libitum): ad libitum (Rat and Mouse SQC Expanded Diet No. 1, Special Diets Services Limited, Witham, Essex, UK)
- Water (e.g. ad libitum): ad libitum drinking water
The diet, drinking water and bedding were routinely analysed and were considered not to contain any contaminants that could reasonably be expected to affect the purpose or integrity of the study.
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C (Any occasional deviations from these targets were considered not to have affected purpose or integrity of the study)
- Humidity (%): 30 to 70% (Any occasional deviations from these targets were considered not to have affected the purpose or integrity of the study)
- Air changes (per hr): at least fifteen per hours
- Photoperiod (hrs dark / hrs light): twelve hours continuous light (06:00 to 18:00) and twelve hours darkness

The animals were provided with environmental enrichment items: wooden chew blocks (B&K Universal Ltd, Hull, UK) and cardboard fun tunnels (Datesand Ltd, Cheshire, UK) or suitable alternatives. These items were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
other: distilled water
Details on dermal exposure:
TEST SITE
- Preparation: on the day before treatment the back and flanks of each animal were clipped free of hair.
- Area of exposure: approximately 10% of the total body surface area
- Type of wrap if used: A piece of surgical gauze was placed over the treatment area and semi-occluded with a piece of self-adhesive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): 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 to remove any residual test material.

- Other: the absorption of the test material was not determined.
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observed for deaths or overt signs of toxicity 0.5, 1, 2 and 4 hours after dosing and subsequently once daily for fourteen days, Individual bodyweights were recorded prior to application of the test material on Day 0 and on Days 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

All animals were subjected to gross necropsy.
Statistics:
Using the mortality data obtained, an estimate of the acute dermal median lethal dose (LD50) of the test material was made.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred.
Clinical signs:
No signs of systemic toxicity occurred.
No signs of dermal irritation occurred.
Body weight:
One female animal showed a slight loss in bodyweight during the second week of the study. All other animals showed expected gains in bodyweight during the study.
Gross pathology:
No abnormalities were noted at necropsy.
Other findings:
No other findings were reported.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: EU-GHS
Conclusions:
The study was performed according to the OECD TG402 without deviations and therefore considered to be of the highest quality (reliability Klimisch 1).The validity criteria of the test system was fulfilled. The test material did not induce any signs of acute dermal toxicity. The test material was considered to be not toxic via the dermal exposure route under the conditions of the test.
Executive summary:

The acute dermal toxicity of the test material was investigated in rats. The test was conducted according to OECD TG402 and EU Method B. 3. 2000 mg/kg bw of the test substance was applied semiocclusive to the shaved skin of rats. After 24 h the animals were unwrapped and observations were made for a period of 14 days. No mortalities, signs of systemic toxicity, signs of dermal irritation, treatment-related body weight changes or pathological abnormalities were reported. The acute dermal median lethal dose (LD50) of the test material, in the Sprague-Dawley CD strain rat was found to be greater than 2000 mg/kg bodyweight.