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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
01 Nov 2011 to 02 Mar 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study was performed according to current OECD/EC guidelines and according to GLP principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
study was conducted according to the acute toxic class method designed for assessment of acute oral toxicity (OECD No. 423): 2x3 females were used instead of 5 animals.
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Qualifier:
according to guideline
Guideline:
other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 12 Nohsan, Notification No. 8147, April 2011; including the most recent partial revisions.
Principles of method if other than guideline:
For treated animals, an external macroscopic examination was conducted next to an internal macroscopic examination.
The study integrity was not adversely affected by the deviation.
GLP compliance:
yes (incl. QA statement)
Remarks:
wih exception of the additional histopathology of the skin.
Test type:
other: acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Oleic acid, compound with (Z)-N-octadec-9-enylpropane-1,3-diamine (2:1)
EC Number:
251-846-4
EC Name:
Oleic acid, compound with (Z)-N-octadec-9-enylpropane-1,3-diamine (2:1)
Cas Number:
34140-91-5
Molecular formula:
C21H44N2.2C18H34O2
IUPAC Name:
oleic acid, compound with (Z)-N-octadec-9-enylpropane-1,3-diamine (2:1)
Test material form:
liquid: viscous
Details on test material:
Chemical registery number : CAS 34140-91-5 / EC 251-846-4
Chemical name : N-[(9Z)-octadec-9-en-1-yl]propane-1,3-diaminium di[(9Z)-octadec-9-enoate

Based on the qualitative and quantitative information on the composition, the sample used are representative of the boundary composition shared and agree by each registrant.

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany.
- Age at study initiation: approx. 12 weeks old
- Weight at study initiation: Body weight variation did not exceed +/- 20% of the sex mean.
- Housing: Individually in Makrolon cages
- Diet: ad libitum, pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany).
- Water: ad libitum, tap water
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.3-21.9
- Humidity (%): 40-59
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: approximately 25 cm² for males and 18 cm² for females
- % coverage: appr. 10% of the total body surface
- Type of wrap if used: a surgical gauze patch (Surgy 1D), successively covered with aluminum foil and Coban elastic bandage

REMOVAL OF TEST SUBSTANCE
- Washing: with tap water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount applied: 2.26 mL/kg bw (= 2000 mg/kg bw)
Duration of exposure:
24 hours
Doses:
2000 mg/kg
No. of animals per sex per dose:
6 females (2x3 f were dosed in a stepwise manner)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: mortality was checked twice daily, clinical signs once daily.
- Frequency of weighing: day 1 (pre-administration), 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: histopathological examination of treated skin with macroscopic abnormalities.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred.
Clinical signs:
other: Hunched posture, lethargy, chromodacryorrhoea, piloerection and/or ptosis were shown by all animals between Days 1 and 10. The treated skin-area of all animals showed general or focal erythema, scales, scabs, a thickened area and/or fissures during the ob
Gross pathology:
Three animals for which an external macroscopic examination was conducted showed scab formation on the dorso-lumbar region of the skin. No other abnormalities were found at macroscopic post mortem examination of the animals.
Other findings:
Treatment-related microscopic skin findings were as follows:
- Ulceration (characterized by full thickness loss of the epithelium through the basement membrane) was present in 5/6 2000 mg/kg treated rats at slight (3/6) or marked (2/6) degree.
- A fibrinous exudate (a focally fibrillar eosinophilic mass of exudative proteinaceous material and cellular debris) was present on the skin surface of all rats at a minimal (1/6), slight (1/6) or moderate (4/6 degree). The most severe exudate was seen in ulcerated areas.
- Acanthosis, thickening/hyperplasia of the epidermis (increase in the number of epithelial cell layers which may extend into the dermis), was present in the non-ulcerated /less severely affected areas of all rats at a slight (5/6) or moderate (1/6) degree. This was likely a reactive response to the test item.
- All rats had lymphogranulocytic inflammation (characterized by a mixture of predominately lymphocytic and some granulocytic inflammatory cells) present in the dermis at minimal (3/6), slight (1/6) or moderate (2/6) degree. Inflammation extended focally into the underlying panniculus muscle which separates the dermis from the underlying subcutaneous tissue.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information for dermal acute toxicity Criteria used for interpretation of results: EU
Conclusions:
The dermal toxicity of oleyl diamine was tested according to current OECD/EC guidelines and under GLP principles. The LD50 was determined to be > 2000mg/kg.

Based on these results, Oleyl diamine, dioleate 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 (2007),
- Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures.
Executive summary:

Assessment of acute dermal toxicity with Oleyl diamine, dioleate in the rat.

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

-      OECD No.423 (2001) "Acute Oral Toxicity, Acute Toxic Class Method"

-      Commission Regulation (EC) No 440/2008, B1tris: "Acute Oral Toxicity, Acute Toxic Class Method"

-      EPA, OPPTS 870.1100 (2002), "Acute Oral Toxicity"

-      JMAFF guidelines (2011) including the most recent partial revisions.

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

-      Commission Regulation (EC) No 440/2008, B3: "Acute Toxicity (Dermal)"

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

Oleyl diamine, dioleate was administered to two subsequent groups of three female Wistar rats 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). Histopathology was conducted on the treated skin area from all rats.

Results: Hunched posture, lethargy, chromodacryorrhoea, piloerection and/or ptosis were shown by all animals between Days 1 and 10. The treated skin-area of all animals showed general or focal erythema, scales, scabs, a thickened area and/or fissures during the observation period.

The changes noted in body weight gain 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.

Three animals for which an external macroscopic examination was conducted showed scab formation on the dorso-lumbar region of the skin. No other abnormalities were found at macroscopic post mortem examination of the animals.

Treatment-related histopathological findings in the treated skin area consisted of ulceration (complete loss of the epidermis) in most rats with a superficial fibrinous exudate (this correlated with the scab formation seen macroscopically) in all rats. There was hyperplasia of the epidermis (acanthosis) in the non-ulcerated areas of all rats. Furthermore, dermal lymphogranulocytic inflammation was present in all rats.

 

The dermal LD50 value of Oleyl diamine, dioleate in Wistar rats was established to exceed 2000 mg/kg body weight.

 

From the histopathological results it is concluded that Oleyl diamine, dioleate is an irritant and has corrosive potential when applied with an occlusive dressing to the rat skin at 2000 mg/kg for 24 hours.

Based on these results, Oleyl diamine, dioleate does not have to be classified and has no obligatory labeling requirement for acute dermal toxicity according to the:

- Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2007),

- Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures.