Orthosulfamuron

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

July 6 to July 9, 1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

IR5878
ISO common name: Orthosulfamuron
Batch number: FCF/T/159-99 (ex 20274/71)
Purity: 93.72 ± 1.05 %

In vitro test system

Details on animal used as source of test system:

Species and Strain: Male and Female New Zealand White rabbits
Age: 2 months
Body weight: 1.8 ÷ 2.3 kg
Housing: for the entire duration of the study the rabbits were kept in metal cages with stainless feeders.
Feed: diet “2 RB 15 GLP certificate” produced by Charles River Italia’s feed licensee Mucedola Srl, Settimo Milanese. The diet was supplemented by the Producer with vitamins and traces elements. The diet was available ad libitum to the animals. Water was distributed ad libitum to the animals.

Details on test system:

Environmental conditions:
Temperature and humidity measured during the study were 19 ± 2°C and 55 ± 10%, respectively.
Light: artificial lighting with a 12-hour circadian cycle (07:00 – 19:00).

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

4 males and 2 females
Animal room controls were set to mantain temperature and relative humidity at 19C +/- 2 and 55% +/- 10 respectively. There were 15-20 air changes per hour. The room was iluminated by artifical lighting with a 12 hour circadian cycle. For the entire duration of the study the rabbits were kept in metal cages with stainless steel feeders. The cages were hung on multiple metal cage racks. The waste was periodically flushed away by a time-programmed siphon system from above.

Test system

Preparation of test site:

clipped

Amount / concentration applied:

0.5g/site

Duration of treatment / exposure:

single application.
Exposure time 3 minutes, 1 hours (first rabbit) and 4 hours (all rabbits)

Observation period:

treatment sites were examined for signs of erythema and edema immediately after the 3 minute and the 1 hour exposure period (first rabbit). These sites were also examined after 72 hours. After removal of the patch applied for 4 hours, animals were examined for erythema and edema and the responses scored at 30 minutes and 60 minutes and at 24, 48 and 72 hours after patch removal. Adjacent areas of untreated skin of each animal served as control for the test.

Number of animals:

4 males and 2 females

Details on study design:

Approximately 24 hours before the test the fur was clipped from the trunk of the animals. Care was taken not to abrade the skin and only animals with intact skin were used.

0.5g of the test article were moistened with about 1mL of water and then applied to a small area (approximately 6cm2) of skin and covered with a gauze patch held in place with non-ittitating tape. The patch was loosely held in contact with the skin by a means of a suitable semocclusive dressing fur the duration of the exposure period. At the end of each exposure period residual test substance was removed with water without altering the existing response or the integrity of the epidermis.

Exposure followed a stepwise procedure: Firstly one rabbit was used and three treatment sites of the skin were prepared. On the first site the patch was applied for an exposure period of 1 hour on the second site. Since no gross reaction was observed the patch was applied for an exposure period of 4 hours on the third skin site. The test was completed using five additional animals each with one patch only, for a 4 hour exposure period.

Adjacent areas of untreated skin of each animal served as control for the test.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 4 hours

Score:

ca. 0

Max. score:

0

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 4 hours

Score:

ca. 0

Max. score:

0

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 3 minutes

Score:

ca. 0

Max. score:

0

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 1 hour

Score:

ca. 0

Max. score:

0

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No changes were seen at any of the skin evaluation of the test article application sites.

Other effects:

Neither mortality nor adverse general clinical modifications were seen during the study.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test article IR5878 when administrated to rabbits by dermal route is to be considered as NON IRRITANT to the rabbit skin.

Executive summary:

IR5878 was moistened with about 1 mL of water and then applied to a small area (approximately 6 cm²) of skin of New Zealand White rabbits (4 males and 2 females). 0.5 mg of IR5878 were applied to the skin of each animal and covered with a gauze patch, which was loosely held in contact with the skin by means of a suitable semi-occlusive dressing for the duration of the exposure periods: 3 minutes, 1 hour (first animal only) and 4 hours.

IR5878 when administrated to rabbits by dermal route is to be considered as NON IRRITANT to the rabbit skin.