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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
16 October 2014 to 30 October 2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted to GLP in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report date:
2014

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
Qualifier:
according to guideline
Guideline:
other: JMAFF 12 Nousan, Notification No 8147
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Benzoic acid, 2-hydroxy-, mono-C14-18-alkyl derivs., sodium salts
Molecular formula:
Na(C21-25H33-41O3)
IUPAC Name:
Benzoic acid, 2-hydroxy-, mono-C14-18-alkyl derivs., sodium salts
Test material form:
other: sticky solid
Details on test material:
- Appearance: Green-black solid
- Storage conditions of test material: At room temperature in the dark

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Strain: Wistar strain Crl:WI (Han) (outbred, SPF-Quality)
- Age at study initiation: Approximately 10 weeks old
- Weight at study initiation: Males 257 to 292 g; females 195 to 209 g. Body weight variation did not exceed ± 20 % of the sex mean.
- Fasting period before study: No
- Housing: During acclimatisation, animals were group housed (cage height 18 cm). During the study, animals were individually housed in labelled cages (height 18 cm) containing sterilised sawdust as bedding material and paper as cage-enrichment.
- Diet: Free access to pelleted rodent diet
- Water: Free access to tap water
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 18 to 24 °C
- Humidity: 40 to 70 % (relative)
- Air changes: at least 10 air changes/hour
- Photoperiod: 12-hour light/12-hour dark cycle

Administration / exposure

Type of coverage:
occlusive
Vehicle:
propylene glycol
Details on dermal exposure:
TEST SITE
- Area of exposure: One day before exposure (Day -1) an area of approximately 5 x 7 cm on the back of each animal was clipped.
- % coverage: The test material was applied on an area of approx. 10 % of the total body surface, i.e. approx. 25 cm² for males and 18 cm² for females.
- Type of wrap if used: The test material was held in contact with the skin with a dressing, consisting of a surgical gauze patch, successively covered with aluminium foil and elastic bandage. A piece of tape was additionally used for fixation of the bandages in females only.

REMOVAL OF TEST MATERIAL
- Washing (if done): Dressings were removed and the skin cleaned of residual test material using tap water.
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied: 10 mL/kg body weight.
- Other: The test material was stirred on a magnetic stirrer during application. The formulation (w/w) was prepared within 4 hours prior to dosing. Homogeneity was accomplished to a visually acceptable level. Adjustment was made for specific gravity of the vehicle.
In order to obtain homogeneity, the test substance formulation was heated in a water bath with a maximum temperature of 73 °C for 63 minutes. The formulation was allowed to cool down to a temperature of maximally 40 °C prior to dosing.

VEHICLE
- Specific gravity: 1.036
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 animals per sex per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: Animals were observed for mortality and viability twice daily. The time of death was recorded as precisely as possible. Body weights were recorded on Day 1 (pre-administration of the test material), Days 8 and 15 and at death (if found dead after Day 1). At periodic intervals on the day of dosing (Day 1) and once daily thereafter until Day 15, animals were observed for clinical signs. The signs were graded according to fixed scales and the time of onset, degree and duration were recorded.
- Necropsy of survivors performed: Yes. At the end of the observation period, all animals were sacrificed by an oxygen/carbon dioxide procedure and subjected to necropsy.
- Other examinations performed: Descriptions of all internal macroscopic abnormalities were recorded.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
One male animal was found dead on Day 2 of the study (one day after treatment). No abnormality was noted at necropsy and the cause of death could not be determined.
Clinical signs:
other: Hunched posture was noted for four animals on Days 6 and/or 7 and for one animal between Days 6 and 10. General erythema, fissures, scales and/or scabs of the skin were seen in the treated skin-area, abdomen, left hindleg and/or flanks of the animals duri
Gross pathology:
Abnormalities of the liver (irregular surface) were found in one male and one female animal at macroscopic post mortem examination.
A diaphragmatic hernia of the left medial liver lobe was seen in one male animal. This finding is occasionally noted among rats of this age and strain and was therefore considered not toxicologically significant.
Macroscopic examination of the other animals did not reveal any abnormalities.

Any other information on results incl. tables

Table 1: Body Weight Data (g)

Dose Group

Animal Number

Day 1

Day 8

Day 15

Males dosed with 2000 mg/kg bw

1

287

275

310

2

292

278

314

3

292

278

327

4

287

282

329

5

257*

-

-

Mean (SD)

283 (15)

278 (3)

320 (9)

Females dosed with 2000 mg/kg bw

6

195

186

204

7

198

185

202

8

209

211

225

9

198

201

212

10

196

192

203

Mean (SD)

199 (6)

195 (11)

209 (10)

*Animal found dead on Day 2; body weight at death 257 g

 

Table 2: Clinical Signs

Parameter

Max Grade

Test Day

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

Males

Animal 1

Erythema (ts)

Scales (ts)

Scabs (a)

Scabs (lh)

Scabs (ts)

 

4

3

3

3

3

 

-

-

-

-

-

 

1

-

-

-

-

 

1

-

-

-

-

 

-

-

-

-

-

 

-

-

-

-

-

 

-

2

-

-

1

 

-

2

-

-

1

 

-

2

2

1

1

 

-

2

-

-

1

 

-

2

-

-

1

 

-

2

-

-

1

 

-

2

-

-

1

 

-

2

-

-

1

 

-

2

-

-

1

 

-

1

-

-

-

Animal 2

Erythema (ts)

Scales (a)

Scales (ts)

Scabs (tt)

 

4

3

3

3

 

-

-

-

-

 

1

-

-

-

 

-

-

-

-

 

-

-

-

-

 

-

-

-

-

 

-

-

2

1

 

-

-

2

1

 

-

1

2

1

 

-

1

2

1

 

-

1

2

1

 

-

1

2

1

 

-

1

2

1

 

-

1

2

1

 

-

1

2

1

 

-

-

1

-

Animal 3

Hunched posture

Erythema (a)

Erythema (ts)

Scales (a)

Scales (ts)

Scabs (a)

Scabs (ts)

 

1

4

4

3

3

3

3

 

-

-

-

-

-

-

-

 

-

-

1

-

-

-

-

 

-

-

2

-

-

-

-

 

-

-

1

-

-

-

-

 

-

-

1

-

-

-

-

 

1

-

-

-

2

-

1

 

-

-

-

-

2

-

1

 

-

1

-

1

2

1

1

 

-

1

-

1

2

1

1

 

-

1

-

1

2

1

1

 

-

1

-

1

2

1

1

 

-

1

-

1

2

1

1

 

-

1

-

1

2

1

1

 

-

1

-

1

2

1

1

 

-

1

-

1

1

-

-

Animal 4

Hunched posture

Erythema (ts)

Fissures (ts)

Scales (a)

Scales (ts)

Scabs (ts)

 

1

4

3

3

3

3

 

-

-

-

-

-

-

 

-

1

-

-

-

-

 

-

1

-

-

-

-

 

-

1

-

-

-

-

 

-

1

-

-

-

-

 

1

1

1

-

2

-

 

1

1

1

-

2

1

 

-

1

-

1

2

1

 

-

1

-

1

2

1

 

-

1

-

1

2

1

 

-

1

-

1

2

1

 

-

1

-

1

2

1

 

-

1

-

1

2

1

 

-

1

-

1

2

1

 

-

-

-

-

1

-

Animal 5

No clinical signs noted

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Females

Animal 6

Erythema (ts)

Scales (a)

Scales (rf)

Scales (ts)

Scabs (lk)

 

4

3

3

3

3

 

-

-

-

-

-

 

1

-

-

-

-

 

-

-

-

-

-

 

-

-

-

-

-

 

-

-

-

-

-

 

-

-

-

2

1

 

-

-

-

-

-

 

-

1

1

2

1

 

-

1

1

2

1

 

-

1

1

2

1

 

-

1

1

2

1

 

-

1

1

2

1

 

-

1

1

2

1

 

-

1

1

2

1

 

-

-

-

-

-

Animal 7

Hunched posture

Erythema (ts)

Fissures (ts)

Scales (lh)

Scales (ts)

Scabs (lh)

Scabs (ts)

 

1

4

3

3

3

3

3

 

-

-

-

-

-

-

-

 

-

1

-

-

-

-

-

 

-

-

-

-

-

-

-

 

-

-

-

-

-

-

-

 

-

-

-

-

-

-

-

 

1

-

1

-

2

-

1

 

1

-

1

-

2

-

1

 

-

-

-

1

3

1

1

 

-

-

-

1

3

1

1

 

-

-

-

1

3

1

1

 

-

-

-

1

3

1

1

 

-

-

-

1

3

1

1

 

-

-

-

1

2

1

1

 

-

-

-

1

2

1

1

 

-

-

-

-

1

-

-

Animal 8

Hunched posture

Erythema (a)

Erythema (ts)

Fissures (lf)

Fissures (ts)

Scales (ts)

Scabs (a)

Scabs (lf)

Scabs (rf)

Scabs (ts)

Hypersensitivity to touch (ts)

 

1

4

4

3

3

3

3

3

3

3

1

 

-

-

-

-

-

-

-

-

-

-

-

 

-

-

1

-

-

-

-

-

-

-

-

 

-

-

1

-

-

-

-

-

-

-

-

 

-

-

-

-

-

-

-

-

-

-

-

 

-

-

-

-

-

-

-

-

-

-

-

 

1

-

-

-

-

2

-

-

-

1

-

 

1

-

-

1

1

2

-

-

1

2

1

 

-

1

-

-

-

1

1

1

1

1

-

 

-

1

-

-

-

1

1

1

1

1

-

 

-

1

-

-

-

1

1

1

1

1

-

 

-

1

-

-

-

1

1

1

1

1

-

 

-

1

-

-

-

1

1

1

1

1

-

 

-

1

-

-

-

1

1

1

1

1

-

 

-

1

-

-

-

1

1

1

1

1

-

 

-

-

-

-

-

1

-

-

-

1

-

Animal 9

Erythema (lh)

Erythema (ts)

Scales (lf)

Scales (lh)

Scales (ts)

 

4

4

3

3

3

 

-

-

-

-

-

 

-

1

-

-

-

 

-

-

-

-

-

 

-

-

-

-

-

 

-

-

-

-

-

 

-

-

-

-

1

 

-

-

-

-

1

 

-

-

1

1

1

 

-

-

1

1

1

 

-

-

1

1

1

 

-

-

1

1

1

 

-

-

1

1

1

 

1

-

1

1

1

 

1

-

1

1

1

 

-

-

-

-

-

Animal 10

Hunched posture

Erythema (a)

Erythema (ts)

Fissures (ts)

Scales (a)

Scales (ts)

Scabs (lf)

Scabs (ts)

Hypersensitivity to touch (ts)

 

1

4

4

3

3

3

3

3

1

 

-

-

-

-

-

-

-

-

-

 

-

-

1

-

-

-

-

-

-

 

-

-

-

-

-

-

-

-

-

 

-

-

-

-

-

-

-

-

-

 

-

-

-

-

-

-

-

-

-

 

1

-

-

2

-

3

-

1

1

 

1

-

-

2

-

3

1

2

1

 

1

1

-

-

1

3

1

2

-

 

1

1

-

-

1

3

1

2

-

 

1

1

-

-

1

3

1

2

-

 

-

1

-

-

1

3

1

2

-

 

-

1

-

-

1

3

1

2

-

 

-

1

-

-

1

1

1

1

-

 

-

1

-

-

1

1

1

1

-

 

-

-

-

-

-

1

-

-

-

ts = treated skin

a = abdomen

lh = left hindleg

rf = right flank

lf = left flank

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study the LD50 value was found to exceed 2000 mg/kg bw.
Executive summary:

The potential of the test material to cause acute dermal toxicity in the rat was investigated in accordance with the standardised guidelines OECD 402, EU Method B.3, EPA OPPTS 870.1200 and JMAFF 12 Nousan, Notification No 8147 under GLP conditions.

The test material was administered to five Wistar rats of each sex by a single dermal application at 2000 mg/kg body weight for 24 hours. After the exposure period, dressings were removed and the skin cleaned of residual test material using tap water. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (Day 15).

One male animal was found dead on Day 2 of the study (one day after treatment). No abnormality was noted at necropsy and the cause of death could not be determined.

Hunched posture was noted for four animals on Days 6 and/or 7 and for one animal between Days 6 and 10. General erythema, fissures, scales and/or scabs of the skin were seen in the treated skin-area, abdomen, left hindleg and/or flanks of the animals during the observation period. The treated skin of two animals was hypersensitive to touch on Days 6 and/or 7.

All animals showed body weight loss or reduced body weight gain (two females) between Days 1 and 8. All animals gained body weight between Days 8 and 15. The changes in body weight in males and females were within the range expected for rats used in this type of study and were therefore considered not indicative of toxicity.

Abnormalities of the liver (irregular surface) were found in one male and one female animal at macroscopic post mortem examination. Macroscopic examination of the other animals did not reveal any abnormalities.

Under the conditions of this study the LD50 value was found to exceed 2000 mg/kg bw.