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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
1986-03-26 to 1986-04-04
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
equivalent or similar to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): FV base E2819.01
- Diethylester dimethyl ammonium chloride
- Substance type: Waxy
- Physical state: White Solid
- Analytical purity: confidential detail
- Impurities (identity and concentrations): None
- Composition of test material, percentage of components: confidential detail
- Isomers composition: NA
- Purity test date: NA
- Lot/batch No.: E-2819.01
- Expiration date of the lot/batch: 1986-06
- Stability under test conditions: Not available
- Storage condition of test material: Room temperature
- Other: None

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harald Schriever, Kaninchenfarm
- Age at study initiation: Not available
- Weight at study initiation: 2.02 - 3.28 kg
- Fasting period before study: Not available
- Housing: Single caging in battery of cages size: 40 cm high, 45 cm wide, 50 cm long with paper roll disposal system
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: At least 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 2 degree C
- Humidity (%): 50-85%
- Air changes (per hr): Not available
- Photoperiod (hrs dark / hrs light): 12 hours daily, light-dark cycle


IN-LIFE DATES: From: 1986-03-26 To: 1986-04-04

Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: Oleum arachidis
Details on dermal exposure:
TEST SITE
- Area of exposure: Dorsal trunk
- % coverage: 15 X 10 cm
- Type of wrap if used: The treated area was covered with gauze pads and the body was wrapped into a rubberized cloth.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): If necessary, with lukewarm water
- Time after start of exposure: 24 hours


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Concentration (if solution): 40% a.i.
- Constant volume or concentration used: no
- For solids, paste formed: no


VEHICLE
- Amount(s) applied (volume or weight with unit): Not available
- Concentration (if solution): Not available
- Lot/batch no. (if required): Not available
- Purity: Not available
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw (male/female)
No. of animals per sex per dose:
3 males and 3 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Daily for observations and Body weights were taken on first and fourteenth day
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
None

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
act. ingr.
Remarks on result:
other: No mortality was observed
Mortality:
No mortality
Clinical signs:
The test substance did not induce any clinical-toxicological symptoms. Slight to moderate erythema and mainly moderate edema were observed at
the treatment sites up to day 3 which resolved afterwards.
Body weight:
Normal weight gain
Gross pathology:
Necropsies performed on all animales at termination exhibited no gross pathological findings.
Other findings:
- Organ weights: None
- Histopathology: None
- Potential target organs: None
- Other observations: None

Any other information on results incl. tables

Skin assessments made at 24 hrs, 3, 7 and 14 days revealed that 2000 mg/kg MDEA-Esterquat produced moderate skin irritation. Slight (3/6 rabbits) to moderate (3/6 rabbits) erythema and moderate edema at the 24 hour reading; slight (5/6 rabbits) to moderate (1/6 rabbits) erythema and slight (3/6 rabbits) to moderate (3/6 rabbits) at day 3. These skin responses resolved at day 7. No atonia, desquamation, fissuring, eschar or exfloliation was observed in the animals in this study.

Erythema and Edema observations at Treated Site

 Animal # Erythema (24 hr)  Edema (24 hr) Erythema (3 days)   Edema (3days)  Erythema (7days)  Edema (7 days) Erythema (14 days)    Edema (14 days) 
 93 (M) 2  1
 72 (M) 1 0
 83 (M)  1
 791 (F)
 792 (F)
799 (F)  
                 
                 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
MDEA-Esterquat C16-18 and C18 unsatd. is practically non - toxic.
Executive summary:

In an acute dermal toxicity study (comparable to OECD guideline 402), groups of 3 male and female New Zeeland With rabbits were dermally exposed to MDEA-Esterquat C16-18 and C18 unsatd.  (40 % a.i) in oleum arachidis for 24 hours to10 x 15 cm of body surface area at doses of 2000 mg/kg bw.  Animals then were observed for14days.

 

Dermal LD50              Males              > 2000 mg/kg bw

                                  Females          > 2000 mg/kg bw

                                  Combined      > 2000 mg/kg bw

 

No mortality occurred in this limit test.

 

MDEA-Esterquat C16-18 and C18 unsatd.  is practically non – toxic in this study.

There were no treatment related clinical signs, necropsy findings or changes in body weight.

 

Slight (1) to moderate (2) erythema and mainly moderate (2) edema with partly decreased intensity were observed at the treatment sites from 24 hours up to the 72 hours after treatment and were fully reversible within 7 days. The mean score were 1.3 for erythema and 1.75 for edema (after 24 and 72 hours). The applied scores of 1 and 2 for erythema and edema were comparable to the scores of the Draize method.