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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:
key study
Study period:
1996-06-28 to 1996-09-13
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study is the result of a structural analogue substance used as read-across substance. Study is conducted according to Guidelines in a GLP certified laboratory.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: Toxic Substance Control Act (TSCA), 40 CFR, Part 798, Subpart A, General Toxicity Testing, Acute Dermal Toxicity, 798, 1100.
Deviations:
no
GLP compliance:
yes
Remarks:
Self-certified
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
-
EC Number:
427-360-5
EC Name:
-
IUPAC Name:
427-360-5
Details on test material:
Description: Pale yellow solid
Stability of test compound: Stable

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
Test animals –
Age at start of adaptation: 10 to 12 weeks
Weight at dosing: At least 2.0-3.0 kilograms
Source: Animals were purchased from a registered commercial breeder.
Acclimatisation period: At least 5 days
Diet: Comercial Rabbit Ration ad libitum.
Water: Tap water ad libitum.
Housing: Individually housed
Environmental conditions -
Temperature: 63 - 73°F
Relative humidity: 30% - 70%
Air changes: 10 - 15 cycles/hour
Photoperiod: 12 hours light/dark cycle.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Animals were selected for the study by clipping the skin of the trunk free of hair approximately 24 hours before application of the test substance. The site of application was not abraded intentionally nor accidentally during preparation. The test substance was introduced under gauze patches two single layers thick and applied directly to the skin of the body surface (approximately 10%) of each of the ten animals. Animals were immobilized and the patches were secured in place by wrapping the entire trunk of the animal with an impervious bandaging.
Duration of exposure:
24 hours
Doses:
A limit test was at a dose level of 2 g/kg
No. of animals per sex per dose:
10 rabbits, 5 male and 5 female
Control animals:
not required
Details on study design:
24 hrs prior to application, 5 male and 5 female rabbits were clipped on the small area (10% of the total body surface area) of the dorsal lumbar region. The test substanc was applied to the test site at a single dose level of 2000 mg/kg bw. A gauze patch was placed over the treated areas. An occlusive dressing (elastic tape) was wrapped around the trunk of the animal to avoid any ingestion of the test article. The dressings were removed 24 hrs later and any excess test material was removed by gentle washing with water.

Animals were observed daily for 14 days for mortality and clinical signs.
Statistics:
Not applicable as no animals died during the course of this study

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: A complete LD50 was not required.
Mortality:
No animals died during the course of the study.
Clinical signs:
No signs of systemic toxicity were evident during the course of the study.
Body weight:
All animals gained weight during the post-treatment period.
Gross pathology:
No signs of toxicity were noted at necropsy in any of the animals.

Any other information on results incl. tables

Table 1: Individual body weights

 

Animal no.

Sex

Body weight (g)

Weight Change

Day 0

Day 7

Day 14

1

Male

2.66

2.94

3.00

0.34

2

Female

2.39

2.67

2.90

0.51

3

Male

2.38

2.59

2.81

0.43

4

Female

2.32

2.67

2.84

0.52

5

Male

2.50

2.78

2.85

0.35

 

Mean ± SD

2.45 ± 0.03

2.73 ± 0.13

2.88 ± 0.07

 

6

Female

2.36

2.64

2.79

0.43

7

Male

2.38

2.66

2.81

0.43

8

Female

2.40

2.61

2.88

0.48

9

Male

2.52

2.80

2.89

0.37

10

Female

2.25

2.53

2.59

0.34

 

Mean ± SD

2.38 ± 0.10

2.65 ± 0.10

2.79 ± 0.12

 

Table 2: Draize Scale Skin Reactions

 

Erythema/Oedema

Animal no.

Sex

Day 1

1

Male

0/0

2

Female

0/0

3

Male

0/0

4

Female

0/0

5

Male

0/0

6

Female

0/0

7

Male

0/0

8

Female

0/0

9

Male

0/0

10

Female

0/0

0: No erythema/No oedema

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
No mortalities were reported in rabbits after a single dermal administration of 2000 mg/kg bw. The acute dermal median lethal dose (LD50) of RA2 was established to be greater than the limit test dose of 2000 mg/kg bw.

Under the conditions of this test and in accordance with provisions of the Global harmonised System of Classification and Labelling of Chemicals (GHS), 2-Propanol, 1', 1" -Nitrilotris-, Acetate (Salt) does not warrant any classification on the basis of its acute dermal toxicity.
Executive summary:

The Read Across test substance RA2 was evaluated for its potential to produce systemic toxicity or death following a single topical 24 hour application to the skin of albino rabbits.

No mortalities, clinical signs or alterations in body weight were seen throughout the course of this study.

Based on the results of this study, the median lethal dose of RA2 to rabbits in an acute dermal toxicity study is greater than 2000 mg/kg bw.