Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
27 May 2016 to 05 July 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Not applicable

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report Date:
2016

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
OECD Guidelines for Testing of Chemicals No. 402 (Section 4: Health Effects) “Acute Dermal Toxicity” adopted on 24 February 1987
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes (incl. certificate)
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): Genamin DMG 75


Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: In-house bred animals
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 10 Weeks
- Weight at study initiation: 222.85 g to 236.20 g (males); 210.48 g to 216.07 g (females)
- Fasting period before study: Not applicable
- Housing: housed individually in a standard polypropylene cage (Size: L 430 x B 285 x H 150 mm)
- Diet (e.g. ad libitum): Teklad Certified (2014SC) Global 14 % Protein Rodent Maintenance Diet - Pellet, manufactured by Envigo Laboratories
- Water (e.g. ad libitum): Deep bore-well water passed through activated charcoal filter and exposed to ultraviolet rays in Aquaguard water filter with purifier
- Acclimation period: 5 Days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.0 to 22.6°C
- Humidity (%): 50 to 69%
- Air changes (per hr): 12 to 15
- Photoperiod (hrs dark / hrs light): 12 hours fluorescent light and 12 hours dark cycle

IN-LIFE DATES: From: 27 May 2016 To: 15 June 2016

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: dorso-lateral area of the trunk
- % coverage: 10% of the total body surface area
- Type of wrap if used: semi-occlusive dressing (crepe bandage)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): using distilled water and dried with absorbent cotton
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg body weight
- Concentration (if solution): Undiluted

Duration of exposure:
24 hours
Doses:
2000 mg/kg body weight
No. of animals per sex per dose:
5
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observed for clinical signs of toxicity and mortality at 30 to 40 min, 1 hour (±10 minutes), 2 hours (±10 minutes), 3 hours (±10 minutes) and 4 hours (±10 minutes) post application of the test item on Day 1 and once daily thereafter for clinical signs of toxicity and twice daily for mortality during the experimental period.

Individual animal body weight was recorded at receipt and on Day 1 (before test item application) and on days 8 and 15 during the experimental period.

- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
Not applicable

Results and discussion

Preliminary study:
Not applicable
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
act. ingr.
Mortality:
The animals did not reveal any mortality during the observation period
Clinical signs:
The animals did not reveal any clinical signs of toxicity during the observation period
Body weight:
No treatment related changes were noted in the body weight and percent change in body weight with respect to Day 1 in both male and females
Gross pathology:
No treatment related gross pathological findings were observed in any of the animals sacrificed at the end of the experimental period.

Any other information on results incl. tables

SUMMARY OF CLINICAL SIGNS OF TOXICITY AND MORTALITYRECORD

Test Dose
(mg/kg body weight)
No. of Animals Sex Clinical Signs of Toxicity Mortality
(No. of Mortality/
No. of Animals Dosed)
Limit Test 2000 5 M N 0/5
Limit Test 2000 5 F N 0/5

SUMMARY OF BODY WEIGHT (g) AND PERCENT CHANGE IN BODY WEIGHT WITH RESPECT TO DAY 1

Test Dose
(mg/kg body weight)
Sex   Body Weight (g) on Day 1 Body Weight (g) on Day 8 Body Weight (g) on Day 15   PercentChange in Body Weight with Respect to Day 1on Day 8 PercentChange in Body Weight with Respect to Day 1on Day 15
Limit Test 2000 M Mean 256.28 278.86 309.23   8.76 20.61
      ±SD 9.89 15.07 18.11   2.14 3.53
      n 5 5 5   5 5
Limit Test 2000 F Mean 222.74 231.8 242.25   4.07 8.76
      ±SD 3.58 3.72 4.82   0.48 1.11
      n 5 5 5   5 5

SUMMARY OF GROSS PATHOLOGICAL FINDINGS

Test Dose
(mg/kg body weight)
No. of Animals Sex Fate External Gross Pathology Findings Internal Gross Pathology Findings
Limit Test 2000 5 M TS NAD NAD
Limit Test 2000 5 F TS NAD NAD

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute dermal toxicity of the registration substance was investigated according to the Guideline OECD 402. Rats were treated at dose of 2000 mg/kg bw. No effects were found. No classification is warranted.
Executive summary:

The acute dermal toxicity of the registration substance was investigated according to the Guideline OECD 402. Five female and five male rats were treated dermally (semi-occlusive) with N,N-Dimethyl-D-Glucamine at dose of 2000 mg/kg bw for 24 hours, observed for clinical effect, including body weight development and food consumption, for up to 14 days and subjected to necropsy. No effect was found throughout observation period and no effect was found upon gross pathological examination.No classification is warranted.