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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:
1984-05-18 to 1984-08-01
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Test procedure according to national (US) standard, which is comparable to OECD guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: EPA TS-792 Acute exposure, dermal toxicity. Health effects test guidelines, EPA, August 1982; EPA 560/6-82-001
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Guanidine hydrochloride

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals 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
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
no mortality occurred
Clinical signs:
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 observed in one animal after 72 h
- loss of hair from the patch site or alopecia was observed in 9/10 animals
- bruising was observed in 3/5 females, this had resolved between 48 and 72 h after patch removal
- burns and slight edema were observed in 2/5 males 30 min after patch removal; the edema resolved by 24 h after patch removal, while the burns were still present after 72 h
- necrosis was present in one male 30 min after patch removal; this lesion was observed throughout the 14-day observation period during which time it was characterised by eschar formation
Body weight:
- no substance-related effects
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:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)
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.