Guanidinium chloride

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1984-05-18 to 1984-08-01

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: EPA TS-792 Acute exposure, dermal toxicity. Health effects test guidelines, EPA, August 1982; EPA 560/6-82-001

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elkhorn Rabbitry, 5265 Starr Way, Watsonville, CA 95076
- Age at study initiation: young adults
- Weight at study initiation: 2.8 to 3.7 kg
- Housing: individually
- Diet (e.g. ad libitum): 150 g of Certified Purina Chow Diet 5322
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 25 d (quarantine, acclimation)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 24°C
- Humidity (%): 46 to 74%, except for spikes up to 94% during cleaning
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

occlusive

Vehicle:

physiological saline

Details on dermal exposure:

TEST SITE
- Area of exposure: 240 cm²
the substance was applied on gauze dressing, taped with hypoallergenic tape (Durapore) and wrapped with bandage (Vetrap)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: after 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- For solids, paste formed: yes, 0.9% saline

Duration of exposure:

24 h

Doses:

2000 mg/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: clinical signs and mortality daily; dermal reactions 0.5, 24, 48, 74 h after removal of the patches; body weights were recorded 7 times during test period
- Necropsy of survivors performed: yes
- Other examinations performed: skin from exposed area was examined microscopically

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

no mortality occurred

Clinical signs:

other: systemic: - no substance-related clinical signs local (dermal): - erythema was observed in all rabbits 30 min after patch removal; 24 h after patch removal the erythema had disappeared in five animals - slight erythema, necrosis and ulceration was observ

Gross pathology:

- epidermal ulceration covered by a fibrinocellular exudate in one male with necrosis and eschar formation
- no other gross findings

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The dermal LD50 of Guanidine hydrochloride in rabbits was > 2000 mg/kg bw.

Executive summary:

In an acute dermal toxicity study similar to OECD guideline 402 groups of 5 young adult New Zealand White rabbits/sex were dermally exposed to Guanidine hydrochloride (98% pure) moistened with 0.9% saline for 24 h to 240 cm² body surface area at a limit dose of  2000  mg/kg bw using occlusive dressing.  Animals then were observed for 14 days.

No mortality occurred. No substance-related systemic effects were observed. Exposure to the test substance caused dermal irritation and eschar formation.

Dermal LD50 > 2000 mg/kg bw.