4-(aminomethyl)octane-1,8-diamine

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2019

Report date:

2019

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity: Fixed Dose Procedure)

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

4-(aminomethyl)octane-1,8-diamine

EC Number:

216-392-3

EC Name:

4-(aminomethyl)octane-1,8-diamine

Cas Number:

1572-55-0

Molecular formula:

C9H23N3

IUPAC Name:

4-(aminomethyl)octane-1,8-diamine

Test material form:

liquid

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source (i.e. manufacturer or supplier) and lot/batch number of test material:
Manufacturer: Ascend Performance Materials Inc.
Lot no.: 1205635
- Purity, including information on contaminants, isomers, etc.:
100%



STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
Ambient
- Stability and homogeneity of the test material in the vehicle/solvent under test conditions (e.g. in the exposure medium) and during storage:
stable
- Stability in the medium, i.e. sensitivity of the test material to hydrolysis and/or photolysis:
stable
- Solubility and stability of the test material in the solvent/vehicle and the exposure medium:
highly soluble
- Reactivity of the test material with the incubation material used (e.g. plastic ware):
non-reactive

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing (e.g. warming, grinding):
none
- Preliminary purification step (if any):
none

Test animals

Species:

rat

Strain:

Sprague-Dawley

Remarks:

Albino

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
Species & Strain: Albino rat; Sprague-Dawley
Justification of Species: The rat is a representative rodent species preferred by various regulatory agencies for use in an acute dermal study.
Source: Texas Animal Specialties; Humble, TX
Date Born/Date Received: 11 Nov & 08 Dec 18 / 10 Jan & 07 Feb 19
Acclimation Period: At least 5 days
Quantity & Sex: 5 female (nulliparous & non-pregnant)
Animal Identification: Ear punch & cage card
Day 0 Weight: 200 - 235 g

ENVIRONMENTAL CONDITIONS
Housing & Cage Type: 1/cage in polycarbonate box with bedding; hutches provided as enrichment
Environmental Controls
Set to Maintain: ∙ 22 + 3°C target temperature ∙ 30 - 70% target humidity
∙ 12-hr light/12-hr dark cycle ∙ 10+ air changes per hour
Actual Temp/Humidity: 20 - 25°C / <25 - 84%
Food: Teklad Global Diets® #2018; available ad libitum
Water: Municipal water supply analyzed by TCEQ Water Utilities Division; available ad libitum from automatic water system

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

Each animal was prepared on the day prior to treatment by clipping the dorsal surface of the trunk free of hair to expose not less than 10% of total body surface area. Care was taken to avoid abrading the skin. Only animals with exposure areas free of pre-existing skin irritation or defects were used for this study. Animals were treated with appropriate amount of undiluted test item. An individual dose was calculated for each animal based on its Day 0 body weight just before exposure. Test item was applied evenly to each exposure area in a thin, uniform layer. The application area was covered with a 2 x 4 in. surgical gauze patch and secured with non-irritating adhesive tape. The trunk of each animal was then wrapped with a veterinary flexible cohesive bandage, secured in place with non-irritating adhesive tape to prevent possible test item ingestion.

After 24 hours, wrappings were removed. Test sites were gently washed with room temperature tap water to remove as much residual test item as possible.

Duration of exposure:

24 h

Doses:

2000 mg/kg bw
1000 mg/kg bw
200 mg/kg bw

No. of animals per sex per dose:

1 per dose for RFT;
2 per dose for main test.

Control animals:

not required

Details on study design:

Healthy albino rats were released from quarantine. Three animals were initially dosed as range-finders, one each at 2000, 1000 and 200 mg/kg; based on results after treatment, two additional animals were later dosed at 200 mg/kg in a similar manner for a main test.

Observations for mortality and clinical/behavioral signs of toxicity were made at least three times on the day of dosing (Day 0) and at least once daily after for 14 days. Individual body weights were recorded just prior to dosing and on Days 7 and 14, or at time of discovery after death.

Observations for evidence of dermal irritation were made on various days after removal of wrappings, up to Day 14 if effects noted.

On Day 14 after dosing, each surviving animal was euthanized by CO2 overdose. All study animals were subjected to gross necropsy and all abnormalities recorded.

Statistics:

A Toxicity Category was assigned using the Flow Chart (Legend A).

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 200 mg/kg bw

Based on:

test mat.

Mortality:

none

Body weight:

lower than 10% body weight loss

Gross pathology:

no clinical signs

Applicant's summary and conclusion

Interpretation of results:

Category 3 based on GHS criteria

Conclusions:

The acute dermal LDso for Hexatran 100 is determined to be greater than 200 mg/kg in female albino rats; therefore, the test item is assigned Toxicity Category 3.