Registration Dossier

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation / corrosion, other
Remarks:
This is in vivo study but validation assistent requires at least one non in vivo study. This is just to satisfy the rules.
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline and GLP study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
3 minutes and approx 2.75 hours (4 hour exposure was terminated early)
Observation period:
1 hour, 24 hours, 48 hours and 72 hours following removal of the test material after the 3 minute exposure.
1 hour following removal of the test material after the 2.75 hour exposure.
Number of animals:
6
Details on study design:
Extreme dermal reactions, indicative of corrosion, were produced, which resulted in termination of the treatment prior to completion of the standard 4-hour exposure.

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 165 min
Score:
6
Reversibility:
no data
Irritant / corrosive response data:
2.75 hour exposure -
Severe dermal necrosis, haemorrhage of the dermal capillaries and loss of skin elasticity were noted at all treated skin sites, one hour after patch removal. The reactions extended beyond the treatment site in two animals and an isolated incident of bleeding was also noted.
An accurate evaluation o f the degree of oedema was not possible due to the other adverse dermal reactions.
All animals were killed for humane reasons and in accordance with Home Office regulations following the one hour observation.

3 minute exposure -
Very slight to well-defined erythema and haemorrhage of the dermal capillaries were noted at all treatment sites one hour after patch removal and persisted at two sites at the 24-hour observation. Well-defined erythema was also noted at one treatment site at the 48- and 72-hour observations. A hardened dark brown/black coloured scab, surrounded by well-defined erythema and with light brown discolouration of the epidermis was also noted at the remaining treatment sites at these times. An accurate evaluation of erythema was not possible at the 48- and 72-hour observations due to the severity of the other dermal reactions.
Very slight oedema was noted at all treatment sites one hour aafter patch removal with moderate to severe oedema noted at all other observation times. Evaluation of oedema was commonly precluded by other adverse dermal reactions.
Green/brown coloured areas of possible dermal necrosis indicative of dermal corrosion were noted at one treated skin site at the 24- and 48-hour observations.
All animals were killed for humane reasons and in accordance with Home Office regulations after the 72-hour observation.

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
The 3 minute exposure did not result in necrosis at the 1-hour observation period but one out of three animals exhibited necrosis at the 24-hour observation. The 2.75 hour exposure resulted in necrosis by the one hour post exposure observation. It was therefore determined that the test substance meets the criteria for classification as a Packing Group II, GHS 1B corrosive, and DSD R35 corrosive.
Executive summary:

In an OECD Guideline 404 study, rabbits were dermally exposed to PACM to assess skin irritancy/corrosivity. The 3-minute exposure did not result in necrosis at the 1-hour observation period but one out of three animals exhibited necrosis at the 24-hour observation. The 2.75-hour exposure resulted in necrosis by the 1-hour post-exposure observation. It was therefore determined that the test substance meets the criteria for classification as a Packing Group II, GHS 1B corrosive, and DSD R35 corrosive.