Amines, tri-C8-10-alkyl

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted to current guidelines under GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Amines, tri-C8-10-alkyl

EC Number:

272-347-8

EC Name:

Amines, tri-C8-10-alkyl

Cas Number:

68814-95-9

Molecular formula:

Unspecified

IUPAC Name:

Amine, tri(n-C8,C10-alkyl)

Test material form:

other: Liquid / colorless, clear

Details on test material:

- Substance type:Amines, tri-C8-10-alkyl
- Physical state: liquid
- Analytical purity: ~97%
- Lot/batch No.:U41B184413
- Expiration date of the lot/batch:February 18, 2014
- Stability under test conditions: The stability of the test item under storage conditions over the study period was guaranteed by the sponsor, and the sponsor holds this responsibility.
- Storage condition of test material:Room temperature

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source:Charles River Wiga GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at study initiation:Young adult animals (male animals approx. 8 weeks, female animals approx. 12 weeks)
- Weight at study initiation:Animals of comparable weight (± 20% of the mean weight) 201-252g
- Fasting period before study:
- Housing:housed in fully air-conditioned rooms, Makrolon cage, type III, Single housing
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C):22°C +- 3°C
- Humidity (%):30 – 70%
- Air changes (per hr):Approx. 10
- Photoperiod (hrs dark / hrs light):12 h / 12 h

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure:40 cm² (corresponds to at least 10% of the body surface)
- % coverage:10 %

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, rinsing of the application site with warm water
- Time after start of exposure: 24h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 6.26 ml/kg bw
- Constant volume or concentration used: no, depends on bw.

Duration of exposure:

24h

Doses:

5000mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

Duration of observation period following administration: 14 days
Frequency of observations and weighing:
- Body weight determination:
-- Individual body weights shortly before administration (day 0), weekly thereafter and on the last day of observation.
- Clinical observations:
-- Recording of clinical signs several times on the day of administration, and at least once daily thereafter each workday for the individual animals.
Scoring of skin findings: Individual readings 30 – 60 minutes after removal of the semi-occlusive dressing (day 1), several times (see results) until the last day of observation.
- Mortality:
-- A check for any dead or moribund animals was made at least once each workday, these records are archived by Bioassay.
- Pathology:
-- Necropsy with gross-pathology examination on the last day of the observation period after sacrifice with CO2 in a chamber with increasing concentrations over time.
Necropsy of survivors performed: yes
- Other examinations performed: assessment of skin reaction

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

discriminating dose

Effect level:

5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred

Clinical signs:

other: No signs of systemic toxicity effects were observed

Gross pathology:

No macroscopic pathologic abnormalities were noted

Other findings:

The following test item-related local effects were recorded during the course of the study:
Well-defined to severe erythema (grade 2 to 4)
Very slight to severe edema (grade 1 to 4)
Incrustations
Additionally, the local clinical signs were noted beyond the application site.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute dermal median lethal dose (LD50) of Amines, tri-C8-10-alkyl was determined to be LD50, dermal, rat > 5000 mg/kg bw

Executive summary:

In an acute dermal toxicity study (Limit Test), young adult Wistar rats(5 males and 5 females)were dermally exposed to a single dose of 5000 mg/kg bw of the undiluted test itemAmines, tri-C8-10-alkyl to the clipped skin (dorsal and dorso-lateral parts of the trunk) and covered by semi-occlusive dressing for 24 hours. The application area comprised at least 10% of the total body surface area. The animals were observed for 14 days.

 

• No mortality occurred.
  
  
• No signs of systemic toxicity effects were observed

 

• The following test item-related local effects were recorded during the course of the study:

 

o  Well-defined to severe erythema (grade 2 to 4)

o  Very slight to severe edema (grade 1 to 4)

o  Incrustations

o  Additionally, the local clinical signswere noted beyond the application site.

 

• Mean body weight of the animals decreased during the first post-exposure observation week, probably due to the severe skin reaction, but increased (only slightly in females) during the second week.

 

• No macroscopic pathologic abnormalities were noted in the animals examined at the end of the study.

Accordingly, the acute dermal median lethal dose (LD₅₀) was determined to be

 

LD₅₀, dermal, rat > 5000 mg/kg bw