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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
10 September 2003 to 07 October 2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was performed to GLP and in line with the standardised guideline OECD 402, EU Method B.3 and EPA OPPTS 870.1200 with no deviations thought to impact the reliability of the presented results.

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
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
452-330-3
EC Name:
-
Cas Number:
314020-40-1
Molecular formula:
C14H20N2O2
IUPAC Name:
2-(2,6-diethyl-4-methyl-phenyl)propanediamide
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Physical state: Powder, yellowish
- Storage condition of test material: Ambient temperature in the dark

Test animals

Species:
rat
Strain:
other: Alpk:APfSD (Wistar-derived)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 8-12 weeks old
- Weight at study initiation: 255-276 g males, 190-207 g females
- Housing: Individually
- Diet: ad libitum
- Water: ad libitum, mains water
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30-70 %
- Air changes (per hr): 15 changes minimum
- Photoperiod (hrs dark / hrs light): 12 hours light (artificial), 12 hours dark

IN-LIFE DATES: From: 10 September 2003 To: 7 October 2003

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: Dorso-lumbar region of each animal (7 cm x 7 cm area was clipped free of hair with veterinary clippers to allow administration of the test material).
- Type of wrap if used: The test substance was applied to the shorn back of each animal and was kept in contact with the skin for approximately 24 hours using an occlusive dressing wrapped around the trunk. Each dressing consisted of a foil backed gauze patch to cover the treated area and was held in place by a cohesive bandage secured with two pieces of surgical tape.

REMOVAL OF TEST SUBSTANCE
- Washing: The dressings were carefully cut using blunt tipped scissors, removed and discarded. The skin at the site of application was cleansed of any residual test material using clean swabs of absorbent cotton wool soaked in clean warm water and then dried gently with clean tissue paper.
- Time after start of exposure: At the end of the 24 hour contact period.

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): The amount of test material applied was calculated for each animal according to its weight at the time of dosing.
- For solids, paste formed: The test material was moistened to a dry paste with a small amount (1 mL) of water.
Duration of exposure:
24 hours
Doses:
2000 mg/kg body weight
No. of animals per sex per dose:
5 males and 5 females per group
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Prior to the start of the study, all rats were examined for any physical or behavioural abnormalities. The animals were observed twice following application on day 1 (only gross abnormalities were noted at this time as the presence of the dressings may have affected the behaviour and movement of the rats). Subsequent observations for signs of systemic toxicity and skin irritation were made once daily up to day 15. The animals were weighed immediately before dosing (day 1) and on days 8 and 15 (termination).
- Necropsy of survivors performed: All animals were killed by an overdose of halothane vapour followed by exsanguination. All animals were examined post mortem. An external observation was performed and a detailed examination of all thoracic and abdominal viscera. All abnormalities were recorded but tissues were not submitted for histopathological examination.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
None of the animals died during the course of the study. None of the animals exhibited signs of systemic toxicity.
Clinical signs:
All the animals were stained yellow by the test substance for up to 5 days. Signs of slight skin irritation were seen in all animals but had completely resolved by day 14.
Body weight:
All animals gained weight during the study.
Gross pathology:
There were no macroscopic abnormalities at examination post mortem.

Any other information on results incl. tables

Table 1: Body weights

Sex

Animal no.

Day

Day of dosing (Day 1)

Day 8

Terminal (Day 15)

Male

1

276

313

357

2

263

309

379

3

255

304

366

4

274

324

392

5

261

307

371

Mean

265.8

311.4

373

S.D.

8.9

7.8

13.3

Female

6

203

227

264

7

190

195

218

8

197

215

242

9

207

222

227

10

195

206

222

Mean

198.4

213.0

234.6

S.D.

6.7

12.8

18.8

Table 2: Irritation observations

Sex

Animal no.

Observation

Day

2

3

4

5

6

7

8

9

10

11

12

13

Male

1

Desquamation

S

S

S

S

S

S

S

Erythema

S

S

S

Oedema

S

Scabs: small scattered

P

P

P

P

P

P

P

2

Desquamation

S

S

S

S

S

S

S

Erythema

S

Scabs: small scattered

P

P

P

P

P

P

P

3

Desquamation

S

S

S

S

S

Oedema

S

Scabs: small scattered

P

Scab: edge of application area

P

P

P

4

Desquamation

S

S

S

S

S

S

S

S

S

S

S

Oedema

S

Scabs: small scattered

P

P

P

P

P

P

P

P

P

P

5

Desquamation

S

S

Oedema

S

Scabs: small scattered

P

Scab: edge of application area

P

P

Female

6

Desquamation

S

S

S

S

S

S

S

S

Erythema

S

S

Oedema

S

Scabs: small scattered

P

P

P

P

P

P

P

P

7

Desquamation

S

S

Scab: edge of application area

P

P

P

P

P

P

8

Desquamation

S

S

S

S

S

S

S

Oedema

S

Scabs: small scattered

P

P

P

P

P

P

P

Scab: edge of application area

P

P

P

9

Desquamation

S

S

10

Oedema

S

Scab: edge of application area

P

P

P

P

P

P

P = Present

S = Slight

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information The test material failed to elicit any toxicological response in any animal during the course of the study. Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the test, the acute dermal median lethal dose of the test material was estimated to be in excess of 2000 mg/kg to male and female rats. The study is considered to be reliable, relevant and adequate for risk assessment and classification and labelling purposes.
Executive summary:

The acute dermal toxicity of the test material was determined in accordance with the standardised guidelines OECD 402, EU Method B.3 and EPA OPPTS 870.1200. Five male and female rats received a single dermal application of 2000 mg/kg of the test material and were assessed daily for the following 14 days for any signs of systemic toxicity. None of the animals died and there were no signs of systemic toxicity. Signs of slight irritation were seen in all animals but had completely resolved by day 14. All animals gained weight during the study. There were no macroscopic abnormalities at examination post mortem. The acute dermal median lethal dose of the test material was estimated to be in excess of 2000 mg/kg to both male and female rats.