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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
No data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Well documented study performed according to a method similar to OECD TG 404. No 14 days follow-up is performed.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
no follow-up during 14 days after exposure
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
- Name of test material (as cited in study report): 3-methoxipropylamin, 85/455

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Gaukler; D-6050 Offenbach/Main. Frg
- Age at study initiation: no data
- Weight at study initiation: 2.87 kg (males); 3.16 kg (females)
- Housing: 1 animal per cage, cage made of stainless stell with wire mesh walk floors (area 40 x 51 cm), no bedding in the cages; saw-dust in the waste trays
- Diet (e.g. ad libitum): Kliba 341.4 mm (Switzerland) - ad libitum
- Water (e.g. ad libitum): about 250 ml tab water per animal per day - ad libitum
- Acclimation period: at least 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): fully air-conditioned rooms: 20-24°C
- Humidity (%): 30-70%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12h (06:00-18:00 light)

Test system

Type of coverage:
other: test patch is secured with a porous dressing (4 layers of absorbent gauze - porous bandage)
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin sites of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): about 0.5 ml of the undiluted test substance is absorbed by the patch (2.5 x 2.5 cm)

Duration of treatment / exposure:
3 min, 1 hour
Observation period:
72 h
Number of animals:
1 male, 2 females per exposure duration
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with lutrol and lutrol / water (1:1)
- Time after start of exposure: after 3 min, resp 1 h exposure
- Readings: 30 - 60 minutes after removal of the test patches and 24h, 48h, 72h after the beginning of the application

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 3 min, 24h, 48h, 72h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 72h
Remarks on result:
other: 3 min exposure
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 3 min, 24h, 48h, 72h
Score:
0.6
Max. score:
4
Reversibility:
not fully reversible within: 72h
Remarks on result:
other: 3 min exposure
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 1h, 24h, 48h, 72h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 72h
Remarks on result:
other: 1h exposure
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 1h, 24h, 48h, 72h
Score:
1.2
Max. score:
4
Reversibility:
not fully reversible within: 72h
Remarks on result:
other: 1h exposure
Irritant / corrosive response data:
Necrosis is observed in all animals exposed for 3 min. At 72h after exposure, full thickness necrosis is confirmed by gross pathology examination.
The mean scores for edema after 3 min exposure are resp 1.0; 0.3; 0.3.

Necrosis is observed in all animals exposed for 1 hour. At 1 and 72h edema was extended beyond the area of exposure in one animal. At 24 and 48h edema was extended in two animals. At 72h after exposure, full thickness necrosis is confirmed by gross pathology examination.
The mean scores for edema after 1h exposure are resp 2.0; 0.7; 1.0

Applicant's summary and conclusion

Interpretation of results:
Category 1A (corrosive) based on GHS criteria
Conclusions:
In an in vivo acute dermal irritation test performed similar to OECD 404, rabbits are exposed to the test substance during resp 3 min and 1h. On the basis of the observations and the lack of reversibility of effects, the substance is considered to be Corrosive Cat 1A according to the CLP Regulation No 1272/2008.