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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
December 1984 - January 1985
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report date:
1985

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
not specified
GLP compliance:
no
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hazelton Dutchland, Inc., Denver, Pennsylvania
- Weight at study initiation: males: 2099 - 2454 g; females: 2093 - 2446 g
- Housing: individually in elevated wire-mesh cages
- Diet (ad libitum): commercial rabbit ration (Purina Lab Rabbit Chow)
- Water (ad libitum): tap water
- Acclimation period: minimum -> one week prior to initiation of treatment

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: back of rabbits, hair was closely clipped; skin was left intact
- Type of wrap if used: nonabsorbent binder composed of rubber damming


REMOVAL OF TEST SUBSTANCE
- Washing (if done): exposure sites were wiped with water
- Time after start of exposure: 24 hours


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Constant volume or concentration used: yes
- For solids, paste formed: no
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
Five
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations for signs of toxic and pharmacologic effects: immediately after dosing, at one and four hours postdose, and once daily thereafter for fourteen consecutive days; mortality/moribundity was recorded twice daily
- Individual body weights were recorded prior to treatment, on Day 7 and at death or termination
- Necropsy of survivors performed: yes
- Other examinations performed: dermal responses were graded and scored on Days 1, 3, 7, 10, and 14 according to the system of Draize (1959)
Statistics:
No data

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality occured during the study.
Clinical signs:
All animals appeared normal throughout the study.
Body weight:
Most animals gained weight from initiation through termination (see table 1).
Gross pathology:
No observable gross pathology was noted in any animal at necropsy.
Other findings:
Dermal Irritation:
- Slight erythema (Grade 1) was noted in one male at day 1.
- All others appeared normal.

Any other information on results incl. tables

Table 1: Individual Body Weights, Acute Dermal Toxicity Study in Rabbits, 2000 mg/kg

Animal Number

Body Weight - Grams

 

Initiation

Day 7

Day 14

Males

E37343

2445

2636

2830

E37344

2267

2449

2650

E37345

2454

2747

2870

E37346

2374

2717

2710

E37347

2099

2150

2300

Females

E37407

2120

2185

2370

E37408

2321

2287

2375

E37409

2446

2730

2960

E37410

2093

2132

2360

E37411

2446

2634

2480

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute dermal LD50 was estimated to be greater than 2000 mg/kg bw.
Executive summary:

In an acute dermal toxicity study, groups of New Zealand White rabbits (5 animals per sex) were dermally exposed to Dicyandiamide for 24 hours at a dose of 2000 mg/kg bw (limit test).  Animals then were observed for 14 days.

Dermal LD50: males > 2000 mg/kg bw; females > 2000 mg/kg bw; combined > 2000 mg/kg bw

No mortality occurred during the study. All animals occurred normal throughout the study. Slight erythema (Grade 1) occurred in one male on Day 1. All others appeared normal. No observable gross pathology was noted in any animal at necropsy. Dicyandimaid is relatively harmless based on the results of this study.