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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
June-July 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report date:
2017

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Qualifier:
according to guideline
Guideline:
other: EC No 440/2008, part B: "Acute Toxicity (Dermal)"
Qualifier:
according to guideline
Guideline:
other: JMAFF Guidelines (2000), including the most recent revisions
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Reference substance name:
Tall oil, maleated
EC Number:
268-859-6
EC Name:
Tall oil, maleated
Cas Number:
68152-93-2
Molecular formula:
UVCB
IUPAC Name:
3,7-dimethyl-14,16-dioxo-19-(propan-2-yl)-15-oxapentacyclo[10.5.2.0²,¹¹.0³,⁸.0¹³,¹⁷]nonadeca-13(17),18-diene-7-carboxylic acid; 8-(7-hexyl-1,3-dioxo-1,3,3a,4,7,7a-hexahydro-2-benzofuran-4-yl)octanoic acid
Test material form:
liquid
Details on test material:
Lot No.: HD0258QH13

Test animals

Species:
rat
Strain:
Wistar
Remarks:
Wistar Han
Sex:
male/female
Details on test animals or test system and environmental conditions:
Test System
Species: Rat
Strain: Crl: WI(Han)
Condition: Outbred, SPF-Quality
Source: Charles River Deutschland, Sulzfeld, Germany
Number of Animals: 5 males and 5 females (females were nulliparous and non-pregnant).
Age at the Initiation of Dosing: Young adult animals (approximately 11 weeks old) were selected.
Weight at the Initiation of Dosing: 185 to 295 g.

Justification for Test System and Number of Animals
The Wistar Han rat was chosen as the animal model for this study as recognized by international guidelines as a recommended test system. The test method and number of animals were based on the test guidelines.
This type of study plan was reviewed and agreed by the Laboratory Animal Welfare Officer and the Ethical Committee of Charles River Den Bosch as required by the Dutch Act on Animal Experimentation (February 1997).

Animal Identification
At study assignment, each animal was identified using a tail mark with indelible ink.

Environmental Acclimation
The animals were allowed to acclimate to the Test Facility toxicology accommodation for at least 5 days before the commencement of dosing.

Selection, Assignment, Replacement, and Disposition of Animals
Animals were assigned to the study at the discretion of the coordinating biotechnician according to body weights, with all animals within ±20% of the sex mean. Animals in poor health or at extremes of body weight range were not assigned to the study.
Before the initiation of dosing, a health inspection was performed and any assigned animal considered unsuitable for use in the study were replaced by alternate animals obtained from the same shipment and maintained under the same environmental conditions.
The disposition of all animals was documented in the study records.

Husbandry
Housing
On arrival, animals were group housed (up to 5 animals of the same sex together) in polycarbonate cages (Makrolon MIV type; height 18 cm.) and following assignment to the study, animals were individually housed in polycarbonate cages (Makrolon MIII type; height 18 cm.) containing sterilized sawdust as bedding material (Lignocel S 8-15, JRS - J.Rettenmaier & Söhne GmbH + CO. KG, Rosenberg, Germany) equipped with water bottles. These housing conditions were maintained unless deemed inappropriate by the Study Director and/or Clinical Veterinarian. The room(s) in which the animals were kept were documented in the study records.
Animals were separated during designated procedures/activities. Each cage was clearly labeled.

Environmental Conditions
Target temperatures of 18 to 24 °C with a relative target humidity of 40 to 70% were maintained. The actual daily mean temperature during the study period was 22 °C with an actual daily mean relative humidity of 48 to 71% (see deviations in Appendix 3). A 12 hour light/12 hour dark cycle was maintained. Ten or greater air changes per hour with 100% fresh air (no air recirculation) were maintained in the animal rooms.

Food
Pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany) was provided ad libitum throughout the study, except during designated procedures.
The feed was analyzed by the supplier for nutritional components and environmental contaminants. Results of the analysis were provided by the supplier and are on file at the Test Facility.
It is considered that there were no known contaminants in the feed that would interfere with the objectives of the study.

Water
Municipal tap-water was freely available to each animal via water bottles.
Periodic analysis of the water was performed, and results of these analyses are on file at the Test Facility.
It is considered that there were no known contaminants in the water that would interfere with the objectives of the study.

Animal Enrichment
For psychological/environmental enrichment, animals were provided with paper (Enviro-dri, Wm. Lillico & Son (Wonham Mill Ltd), Surrey, United Kingdom), except when interrupted by study procedures/activities.

Veterinary Care
Veterinary care was available throughout the course of the study; however, no examinations or treatments were required.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
A single dose of test item was administered to the appropriate animals by dermal application on Day 1. One day before dosing, an area of approximately 5x7 cm on the back of the animals was clipped. The test item was applied in an area of approximately 10% of the total body surface, i.e. approximately 25 cm² for males and 18 cm² for females. The test item was held in contact with the skin with a dressing, consisting of a surgical gauze patch (Surgy 1D), successively covered with aluminum foil and Coban elastic bandage. A piece of Micropore tape was additionally used for fixation of the bandages in females only.
Duration of exposure:
24 h
Doses:
The dose level was 2000 mg/kg body weight.
No. of animals per sex per dose:
5 males and 5 females (females were nulliparous and non-pregnant). Each one exposed to 2000 mg/kg test item
Control animals:
no
Details on study design:
Mortality/Moribundity Checks
Throughout the study, animals were observed for general health/mortality and moribundity twice daily, in the morning and at the end of the working day. Animals were not removed from cage during observation, unless necessary for identification or confirmation of possible findings.

Clinical Observations

Postdose Observations
Postdose observations were performed at periodic intervals on the day of dosing (at least three times) and once daily thereafter. The observation period was 14 days.
All the animals were examined for reaction to dosing. The onset, intensity and duration of these signs was recorded (if appropriate), particular attention being paid to the animals during and for the first hour after dosing.

Body Weights
Animals were weighed individually on Day 1 (predose), 8 and 15.

Terminal Procedures
All moribund animals and animals surviving to the end of the observation period were sacrificed by oxygen/carbon dioxide procedure. All animals assigned to the study were subjected to necropsy and descriptions of all internal macroscopic abnormalities were recorded.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred.
Clinical signs:
other: Lethargy, hunched posture, rales, piloerection, chromodacryorrhoea (snout), hypothermia and/or hypersensitivity to touch were noted for the animals between Days 1 and 7. Focal erythema, thickened area, alopecia, necrosis, scales, scabs, brown staining we
Gross pathology:
No abnormalities were found at macroscopic post mortem examination of the animals.

Any other information on results incl. tables

TABLE 1 MORTALITY DATA

 
TEST DAY
HOURS AFTER TREATMENT
 

 
1
0
 

 
1
2
 

 
1
4
 

 
2

 

 
3

 

 
4

 

 
5

 

 
6

 

 
7

 

 
8

 

 
9

 

 
10

 

 
11

 

 
12

 

 
13

 

 
14

 

 
15

 

'

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

MALES 2000 MG/KG

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

.

FEMALES 2000 MG/KG

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

.

TABLE 2 CLINICAL SIGNS

 

 
TEST DAY
HOURS AFTER TREATMENT
 

 

MAX
GRADE
 

 
1
0

 

 
1
2

 

 
1
4

 

 
2

 

 
3

 

 
4

 

 
5

 

 
6

 

 
7

 

 
8

 

 
9

 

 
10

 

 
11

 

 
12

 

 
13

 

 
14

 

 
15

 

'

 


MALES 2000 MG/KG

 

ANIMAL 1

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

.

 

Posture

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

.

 

 Hunched posture

(1)

-

-

-

1

1

1

1

-

-

-

-

-

-

-

-

-

-

.

 

Skin / fur

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

.

 

 Erythema focal (Treated skin)

(4)

-

-

-

2

3

2

1

1

1

1

1

-

-

-

-

-

-

.

 

 Necrosis (Treated skin)

(3)

-

-

-

1

1

-

-

-

-

-

-

-

-

-

-

-

-

.

 

 Scales (Treated skin)

(3)

-

-

-

-

-

-

-

-

-

1

1

-

-

-

-

-

-

.

 

 Scabs (Treated skin)

(3)

-

-

-

-

-

1

1

1

1

-

-

-

-

-

-

-

-

.

 

 Brown staining (Treated skin)

(1)

-

-

-

1

1

1

1

1

1

1

1

1

1

1

1

-

-

.

 

Various

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

.

 

 Hypersensitivity to touch

(1)

-

-

-

-

1

-

-

-

-

-

-

-

-

-

-

-

-

.

 

ANIMAL 2

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

.

 

Behavior

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

.

 

 Lethargy

(3)

-

-

-

1

-

-

-

-

-

-

-

-

-

-

-

-

-

.

 

Posture

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

.

 

 Hunched posture

(1)

-

-

-

1

1

1

-

-

-

-

-

-

-

-

-

-

-

.

 

Skin / fur

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

.

 

 Erythema focal (Treated skin)

(4)

-

-

-

1

1

1

1

1

1

1

1

-

-

-

-

-

-

.

 

 Piloerection

(1)

-

-

1

1

-

-

-

-

-

-

-

-

-

-

-

-

-

.

 

 Scales (Treated skin)

(3)

-

-

-

-

-

-

-

-

-

1

1

-

-

-

-

-

-

.

 

 Brown staining (Treated skin)

(1)

-

-

-

1

1

1

1

1

1

1

1

1

1

1

1

-

-

.

 

Various

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

.

 

 Hypothermia

(1)

-

-

-

1

-

-

-

-

-

-

-

-

-

-

-

-

-

.

 

ANIMAL 3

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

.

 

Posture

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

.

 

 Hunched posture

(1)

-

-

-

1

1

1

1

1

-

-

-

-

-

-

-

-

-

.

 

Skin / fur

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

.

 

 Erythema focal (Treated skin)

(4)

-

-

-

1

1

1

1

1

1

-

-

-

-

-

-

-

-

.

 

 Thickened area (Treated skin)

(3)

-

-

-

1

1

1

1

-

-

-

-

-

-

-

-

-

-

.

 

 Brown staining (Treated skin)

(1)

-

-

-

1

1

1

1

1

1

-

-

-

-

-

-

-

-

.

 

ANIMAL 4

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

.

 

Behavior

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

.

 

 Lethargy

(3)

-

-

-

1

-

-

-

-

-

-

-

-

-

-

-

-

-

.

 

Posture

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

.

 

 Hunched posture

(1)

-

-

-

1

1

1

1

1

1

-

-

-

-

-

-

-

-

.

 

Skin / fur

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

.

 

 Erythema focal (Treated skin)

(4)

-

-

-

1

2

2

1

1

1

-

-

-

-

-

-

-

-

.

 

 Scales (Treated skin)

(3)

-

-

-

-

-

-

-

2

2

1

1

-

-

-

-

-

-

.

 

 Thickened area (Treated skin)

(3)

-

-

-

1

1

1

1

-

-

-

-

-

-

-

-

-

-

.

 

 Brown staining (Treated skin)

(1)

-

-

-

1

1

1

1

1

1

1

1

1

1

1

1

-

-

.

 

Secretion / excretion

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

.

 

 Chromodacryorrhoea (Snout)

(3)

-

1

1

-

-

-

-

-

-

-

-

-

-

-

-

-

-

.

 

ANIMAL 5

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

.

 

Behavior

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

.

 

 Lethargy

(3)

-

-

-

1

-

-

-

-

-

-

-

-

-

-

-

-

-

.

 

Posture

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

.

 

 Hunched posture

(1)

-

-

-

1

-

-

-

-

-

-

-

-

-

-

-

-

-

.

 

Breathing

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

.

 

 Rales

(3)

-

-

-

1

1

-

-

-

-

-

-

-

-

-

-

-

-

.

 

Skin / fur

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

.

 

 Erythema focal (Treated skin)

(4)

-

-

-

1

2

2

1

1

1

-

-

-

-

-

-

-

-

.

 

 Piloerection

(1)

-

-

-

1

-

-

-

-

-

-

-

-

-

-

-

-

-

.

 

 Scales (Treated skin)

(3)

-

-

-

-

-

-

-

-

1

1

1

-

-

-

-

-

-

.

 

 Scabs (Treated skin)

(3)

-

-

-

-

-

-

-

-

1

-

-

-

-

-

-

-

-

.

 

 Brown staining (Treated skin)

(1)

-

-

-

1

1

1

1

1

1

1

1

1

1

1

1

-

-

.

 

Secretion / excretion

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

.

 

 Chromodacryorrhoea (Snout)

(3)

-

1

1

1

-

-

-

-

-

-

-

-

-

-

-

-

-

.

 

 

- = Sign not observed

TABLE 2 CLINICAL SIGNS (continued)

 

 
TEST DAY
HOURS AFTER TREATMENT
 

 

MAX
GRADE
 

 
1
0

 

 
1
2

 

 
1
4

 

 
2

 

 
3

 

 
4

 

 
5

 

 
6

 

 
7

 

 
8

 

 
9

 

 
10

 

 
11

 

 
12

 

 
13

 

 
14

 

 
15

 

'

 


FEMALES 2000 MG/KG

 

ANIMAL 6

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

.

 

Posture

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

.

 

 Hunched posture

(1)

-

-

-

1

-

-

1

1

1

-

-

-

-

-

-

-

-

.

 

Skin / fur

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

.

 

 Erythema focal (Treated skin)

(4)

-

-

-

1

1

2

1

1

1

-

-

-

-

-

-

-

-

.

 

 Scales (Treated skin)

(3)

-

-

-

-

-

-

-

-

1

1

1

-

-

-

-

-

-

.

 

 Thickened area

(3)

-

-

-

1

-

-

-

-

-

-

-

-

-

-

-

-

-

.

 

 Brown staining (Treated skin)

(1)

-

-

-

1

1

1

1

1

1

1

1

-

-

-

-

-

-

.

 

Various

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

.

 

 Hypersensitivity to touch

(1)

-

-

-

1

-

-

-

-

-

-

-

-

-

-

-

-

-

.

 

ANIMAL 7

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

.

 

Posture

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

.

 

 Hunched posture

(1)

-

-

-

1

1

1

1

1

-

-

-

-

-

-

-

-

-

.

 

Skin / fur

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

.

 

 Erythema focal (Treated skin)

(4)

-

-

-

1

1

1

1

1

-

-

-

-

-

-

-

-

-

.

 

 Scales (Treated skin)

(3)

-

-

-

-

-

-

-

2

1

1

1

-

-

-

-

-

-

.

 

 Brown staining (Treated skin)

(1)

-

-

-

1

1

1

1

1

1

1

1

-

-

-

-

-

-

.

 

Secretion / excretion

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

.

 

 Chromodacryorrhoea (Snout)

(3)

-

1

1

-

-

-

-

-

-

-

-

-

-

-

-

-

-

.

 

Various

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

.

 

 Hypersensitivity to touch

(1)

-

-

-

1

1

1

-

-

-

-

-

-

-

-

-

-

-

.

 

ANIMAL 8

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

.

 

Posture

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

.

 

 Hunched posture

(1)

-

-

-

1

1

1

1

1

1

-

-

-

-

-

-

-

-

.

 

Skin / fur

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

.

 

 Erythema focal (Treated skin)

(4)

-

-

-

1

1

1

1

1

1

-

-

-

-

-

-

-

-

.

 

 Alopecia

(3)

-

-

-

-

-

-

-

-

1

1

1

1

1

1

1

1

1

.

 

 Scales (Treated skin)

(3)

-

-

-

-

-

-

-

-

1

1

1

-

-

-

-

-

-

.

 

 Scabs (Treated skin)

(3)

-

-

-

-

-

-

-

-

1

-

-

-

-

-

-

-

-

.

 

 Brown staining (Treated skin)

(1)

-

-

-

1

1

1

1

1

1

1

1

-

-

-

-

-

-

.

 

ANIMAL 9

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

.

 

Posture

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

.

 

 Hunched posture

(1)

-

-

-

1

1

1

1

-

-

-

-

-

-

-

-

-

-

.

 

Skin / fur

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

.

 

 Erythema focal (Treated skin)

(4)

-

-

-

1

2

2

2

1

1

-

-

-

-

-

-

-

-

.

 

 Scales (Treated skin)

(3)

-

-

-

-

-

-

-

2

2

1

1

-

-

-

-

-

-

.

 

 Thickened area (Treated skin)

(3)

-

-

-

1

2

1

1

1

-

-

-

-

-

-

-

-

-

.

 

 Brown staining (Treated skin)

(1)

-

-

-

1

1

1

1

1

1

1

1

-

-

-

-

-

-

.

 

Various

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

.

 

 Hypersensitivity to touch

(1)

-

-

-

1

1

-

-

-

-

-

-

-

-

-

-

-

-

.

 

ANIMAL 10

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

.

 

Posture

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

.

 

 Hunched posture

(1)

-

-

-

1

1

1

1

-

-

-

-

-

-

-

-

-

-

.

 

Skin / fur

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

.

 

 Erythema focal (Treated skin)

(4)

-

-

-

1

2

2

2

1

1

-

-

-

-

-

-

-

-

.

 

 Scales (Treated skin)

(3)

-

-

-

-

-

1

1

2

2

1

1

-

-

-

-

-

-

.

 

 Thickened area

(3)

-

-

-

1

1

1

1

1

-

-

-

-

-

-

-

-

-

.

 

 Brown staining (Treated skin)

(1)

-

-

-

1

1

1

1

1

1

1

1

-

-

-

-

-

-

.

 

Secretion / excretion

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

.

 

 Chromodacryorrhoea (Snout)

(3)

-

1

1

-

-

-

-

-

-

-

-

-

-

-

-

-

-

.

 

Various

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

.

 

 Hypersensitivity to touch

(1)

-

-

-

1

1

-

-

-

-

-

-

-

-

-

-

-

-

.

 

 

- = Sign not observed

TABLE 3 BODY WEIGHTS (GRAM)

 

 
SEX/DOSE LEVEL
 

 
ANIMAL
 

 
DAY 1
 

 
DAY 8
 

 
DAY 15
 

'


MALES 2000 MG/KG

 

 

1

295

299

321

.

 

2

288

291

317

.

 

3

292

302

322

.

 

4

282

281

303

.

 

5

288

287

315

.

 

 

 

 

 

.

 

MEAN

289

292

316

.

 

ST.DEV.

5

9

8

.

 

N

5

5

5

.

 

 

 

 

 

.


FEMALES 2000 MG/KG

 

 

6

206

208

210

.

 

7

210

202

211

.

 

8

202

198

203

.

 

9

223

226

234

.

 

10

185

188

192

.

 

 

 

 

 

.

 

MEAN

205

204

210

.

 

ST.DEV.

14

14

15

.

 

N

5

5

5

.

 

 

 

 

 

.

TABLE 4 MACROSCOPIC FINDINGS

 

 
ANIMAL
 

 
ORGAN
 

 
FINDING
 

 
DAY OF DEATH
 

'


MALES 2000 MG/KG

 

1

 

No  findings noted

Scheduled necropsy

.

 

 

 

Day 15 after treatment

.

2

 

No  findings noted

Scheduled necropsy

.

 

 

 

Day 15 after treatment

.

3

 

No  findings noted

Scheduled necropsy

.

 

 

 

Day 15 after treatment

.

4

 

No  findings noted

Scheduled necropsy

.

 

 

 

Day 15 after treatment

.

5

 

No  findings noted

Scheduled necropsy

.

 

 

 

Day 15 after treatment

.


FEMALES 2000 MG/KG

 

6

 

No  findings noted

Scheduled necropsy

.

 

 

 

Day 15 after treatment

.

7

 

No  findings noted

Scheduled necropsy

.

 

 

 

Day 15 after treatment

.

8

 

No  findings noted

Scheduled necropsy

.

 

 

 

Day 15 after treatment

.

9

 

No  findings noted

Scheduled necropsy

.

 

 

 

Day 15 after treatment

.

10

 

No  findings noted

Scheduled necropsy

.

 

 

 

Day 15 after treatment

.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The dermal LD50 value of EnvaMul 600 in Wistar rats was established to exceed 2000 mg/kg body weight.
Based on these results, EnvaMul 600 does not have to be classified and has no obligatory labelling requirement for acute dermal toxicity according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2015) (including all amendments) and Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments).
Executive summary:

The objective of this study was to determine the potential toxicity of EnvaMul 600, when given by a single dermal dose.

 

The study was carried out based on the guidelines described in:

·        OECD No. 402 (1987) "Acute Dermal Toxicity"

·        EC No 440/2008, part B: "Acute Toxicity (Dermal)"

·        EPA, OPPTS 870.1200 (1998), "Acute Dermal Toxicity"

·        JMAFF Guidelines (2000), including the most recent revisions.

 

EnvaMul 600 was administered to five Wistar rats of each sex by a single dermal application at 2000 mg/kg body weight for 24 hours. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (Day 15).

 

No mortality occurred.

Lethargy, hunched posture, rales, piloerection, chromodacryorrhoea (snout), hypothermia and/or hypersensitivity to touch were noted for the animals between Days 1 and 7.

Focal erythema, thickened area, alopecia, necrosis, scales, scabs, brown staining were seen in the treated skin-area of the animals during the observation period. These local effects were considered not to have affected the conclusion of the study.

The mean body weight gain during the observation period was within the range expected for rats used in this type of study.

No abnormalities were found at macroscopic post mortem examination of the animals.

 

The dermal LD50 value of EnvaMul 600 in Wistar rats was established to exceed 2000 mg/kg body weight.

Based on these results, EnvaMul 600 does not have to be classified and has no obligatory labelling requirement for acute dermal toxicity according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2015) (including all amendments) and Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments).